Alliance Health
North Carolina
Submit Application and Resume to Alliance Health at https://www.alliancehealthplan.org
Reference Requisition DIREC001779
The Director of Quality Management develops strategies to drive continuous improvement through all levels of the organization. The Director works with other departments/divisions on the development of key metrics, data gathering, and compliance with quality system standards to align continuous improvement efforts with organization strategies and initiatives.
This position will allow the successful candidate to work a primarily remote schedule. They must reside in North Carolina and will be required to come into the Alliance office in Morrisville or Charlotte, NC, for meetings with staff as needed.
Responsibilities & Duties
Develop and Implement Department goals and objectives
Work with the SVP of Quality Management to establish and implement department goals and objectives.
Work with the SVP of Quality Management to develop a quality management plan that defines and describes quality standards and assessments
Research and incorporate best practices into quality management operations
Analyze, updates, and modifies standard operating procedures and processes to continually improve department operations
Oversee all regulatory body surveys; record concerns and develop procedures to handle concerns identified from survey data
Staff Management and Development
Work with Human Resources and the SVP of Quality Management to maintain and retain a highly qualified and well-trained workforce
Ensure staff are well trained in and comply with all organization and department policies, procedures, and business processes
Organize workflows and ensure staff understand their roles and responsibilities
Ensure the department has the needed tools and resources to achieve organizational goals and to support employees and ensure compliance with licensure, regulatory, and accreditation requirements
Actively establish and promote a positive, diverse, and inclusive working environment that builds trust
Ensure all staff are treated with respect and dignity
Ensure standards are transparent and applied consistently, impartially, and ethically over time and across all staff members
Work to resolve conflicts and disputes, ensuring that all participants are given a voice
Set goals for performance and deadlines in line with organization goals and vision
Effectively communicate feedback and provide ongoing coaching and mentoring to staff and support a learning environment to advance team skills and professional development
Cultivate and encourage efforts to expand cross-team collaboration and partnership
Collaborate with internal and external stakeholders on quality measurement/ performance initiatives
Lead efforts on and collaborate with others on Healthcare Effectiveness Data and Information Set (HEDIS) performance
Collaborate with state of North Carolina leaders on quality initiatives
Review and implement new technological tools and processes and foster a team concept with internal and external stakeholders
Support and collaborate with other leaders on Health Plan National Committee for Quality Assurance (NCQA) Accreditation and others
Oversee quality improvement aspects of risk adjustment processes for all products
Work collaboratively with other departments/divisions on the development of key metrics, continuous improvement, and compliance with quality system standards
Oversee performance and outcome measurement activities including tracking key indicators throughout the year, aggregating data, analyzing quarterly and annual trends, and working collaboratively with program staff regarding follow-up activities and improvements, as required
Work collaboratively with departments to identify opportunities to redesign processes that meet principles of enhanced effectiveness and efficiency within the organization
Work with internal departments to support the Data Science team’s introduction of machine learning techniques, such as the automatic interpretation of multiple text fields in databases to reach decisions
Collaborate with the provider network staff on gaps analyses and strategic planning
Oversee development of quality improvement data gathering and reporting
Present quality initiative findings and results of improvement efforts and ongoing performance measures to SVP of Quality
Streamline the internal reporting process including the management of adhoc reporting request by creating an internal systematic process
Oversee appeals and grievance trending and reporting and collaborate with other leaders to mitigate risk
Oversee analyses of data related to deviations of good clinical practice (GCP), including development of clear hypotheses and use of appropriate statistical analyses utilizing data from disparate sources (databases/tables) to develop actionable insights that support continuous process improvement
Oversee efforts to automate the generation of Dashboards and Reports
Develops, collects, prepares and analyzes quality of care data using computer designed data retrieval and storage; coordinates activities with the information technology department to collect information that can be used to examine patterns of outcomes of service delivery
Minimum Requirements
Education & Experience
Registered Nurse Required (Medicaid experience preferred)
Master’s degree in Nursing, Quality Management, Health Management or Healthcare related field required
Five (5) years’ demonstrated Statistics/analytics and/or quality management/quality improvement experience in a managed care environment preferred
Five (5) years of experience in a clinical healthcare setting
Three (3) years or more management experience.
Training in data analysis, project planning or quality management is a plus.
Analysis tools such as SAS/SPSS/R, data storage principles and SQL is a plus
Knowledge, Skills, & Abilities
Thorough knowledge of public administration principles and methods, including goal setting, program development and administration, budgeting, and staff supervision
Thorough knowledge of laws, rules and regulations governing LME/MCO activities and standards;
Thorough knowledge of laws, rules and regulations governing LME/MCO activities and standards;
Knowledge of the social, political and economic issues including available public and private community resources;
Knowledge of principles of management and administration including planning, budgeting, human resource management, finance, and computer applications
Experience with project management, lean, DMAIC, Six Sigma, Kaizen PDCA cycles, Pareto analysis, techniques for statistical analysis, survey design and methodologies, and training
Extensive knowledge and understanding of business processes analysis and enhancing operations to accomplish business objectives
Knowledge of the organization and functions of departments and agencies which comprise county government
Strong analytical skills and ability to solve complex technical problems
Familiarity with software programs (Word, Excel, Access, Visio, PowerPoint, and statistical software packages like SAS, SPSS, or R) as well as an understanding of data storage principles and SQL is necessary
Ability to lead and motivate staff
Ability to develop and implement goals, objectives, policies, procedures, work standards and internal controls
Ability to analyze complex administrative and regulatory problems, evaluate alternatives and adopt effective courses of action
Ability to prepare clear and concise reports, correspondence and make effective presentations
Ability to exercise sound independent judgment within general policy guidelines
Ability to develop proposals and programs which respond to long- and short-range problems detected during analysis
Ability to develop proposals and programs which respond to long- and short-range problems detected during analysis
Ability to comprehend and analyze complex organizational and procedural problems involving work production, work flow, forms, records, systems and staff utilization
Ability to prepare and interpret a variety of reports, charts, layouts and other materials using computer and information services technology
Ability to enlist the cooperation of officials of various agencies to implement policy and procedural changes
Ability to present ideas effectively, both orally and in writing
Salary Range
$75,438.27 to $129,865.03/Annually
Submit Application and Resume to Alliance Health at https://www.alliancehealthplan.org
Reference Requisition DIREC001779
The Director of Quality Management develops strategies to drive continuous improvement through all levels of the organization. The Director works with other departments/divisions on the development of key metrics, data gathering, and compliance with quality system standards to align continuous improvement efforts with organization strategies and initiatives.
This position will allow the successful candidate to work a primarily remote schedule. They must reside in North Carolina and will be required to come into the Alliance office in Morrisville or Charlotte, NC, for meetings with staff as needed.
Responsibilities & Duties
Develop and Implement Department goals and objectives
Work with the SVP of Quality Management to establish and implement department goals and objectives.
Work with the SVP of Quality Management to develop a quality management plan that defines and describes quality standards and assessments
Research and incorporate best practices into quality management operations
Analyze, updates, and modifies standard operating procedures and processes to continually improve department operations
Oversee all regulatory body surveys; record concerns and develop procedures to handle concerns identified from survey data
Staff Management and Development
Work with Human Resources and the SVP of Quality Management to maintain and retain a highly qualified and well-trained workforce
Ensure staff are well trained in and comply with all organization and department policies, procedures, and business processes
Organize workflows and ensure staff understand their roles and responsibilities
Ensure the department has the needed tools and resources to achieve organizational goals and to support employees and ensure compliance with licensure, regulatory, and accreditation requirements
Actively establish and promote a positive, diverse, and inclusive working environment that builds trust
Ensure all staff are treated with respect and dignity
Ensure standards are transparent and applied consistently, impartially, and ethically over time and across all staff members
Work to resolve conflicts and disputes, ensuring that all participants are given a voice
Set goals for performance and deadlines in line with organization goals and vision
Effectively communicate feedback and provide ongoing coaching and mentoring to staff and support a learning environment to advance team skills and professional development
Cultivate and encourage efforts to expand cross-team collaboration and partnership
Collaborate with internal and external stakeholders on quality measurement/ performance initiatives
Lead efforts on and collaborate with others on Healthcare Effectiveness Data and Information Set (HEDIS) performance
Collaborate with state of North Carolina leaders on quality initiatives
Review and implement new technological tools and processes and foster a team concept with internal and external stakeholders
Support and collaborate with other leaders on Health Plan National Committee for Quality Assurance (NCQA) Accreditation and others
Oversee quality improvement aspects of risk adjustment processes for all products
Work collaboratively with other departments/divisions on the development of key metrics, continuous improvement, and compliance with quality system standards
Oversee performance and outcome measurement activities including tracking key indicators throughout the year, aggregating data, analyzing quarterly and annual trends, and working collaboratively with program staff regarding follow-up activities and improvements, as required
Work collaboratively with departments to identify opportunities to redesign processes that meet principles of enhanced effectiveness and efficiency within the organization
Work with internal departments to support the Data Science team’s introduction of machine learning techniques, such as the automatic interpretation of multiple text fields in databases to reach decisions
Collaborate with the provider network staff on gaps analyses and strategic planning
Oversee development of quality improvement data gathering and reporting
Present quality initiative findings and results of improvement efforts and ongoing performance measures to SVP of Quality
Streamline the internal reporting process including the management of adhoc reporting request by creating an internal systematic process
Oversee appeals and grievance trending and reporting and collaborate with other leaders to mitigate risk
Oversee analyses of data related to deviations of good clinical practice (GCP), including development of clear hypotheses and use of appropriate statistical analyses utilizing data from disparate sources (databases/tables) to develop actionable insights that support continuous process improvement
Oversee efforts to automate the generation of Dashboards and Reports
Develops, collects, prepares and analyzes quality of care data using computer designed data retrieval and storage; coordinates activities with the information technology department to collect information that can be used to examine patterns of outcomes of service delivery
Minimum Requirements
Education & Experience
Registered Nurse Required (Medicaid experience preferred)
Master’s degree in Nursing, Quality Management, Health Management or Healthcare related field required
Five (5) years’ demonstrated Statistics/analytics and/or quality management/quality improvement experience in a managed care environment preferred
Five (5) years of experience in a clinical healthcare setting
Three (3) years or more management experience.
Training in data analysis, project planning or quality management is a plus.
Analysis tools such as SAS/SPSS/R, data storage principles and SQL is a plus
Knowledge, Skills, & Abilities
Thorough knowledge of public administration principles and methods, including goal setting, program development and administration, budgeting, and staff supervision
Thorough knowledge of laws, rules and regulations governing LME/MCO activities and standards;
Thorough knowledge of laws, rules and regulations governing LME/MCO activities and standards;
Knowledge of the social, political and economic issues including available public and private community resources;
Knowledge of principles of management and administration including planning, budgeting, human resource management, finance, and computer applications
Experience with project management, lean, DMAIC, Six Sigma, Kaizen PDCA cycles, Pareto analysis, techniques for statistical analysis, survey design and methodologies, and training
Extensive knowledge and understanding of business processes analysis and enhancing operations to accomplish business objectives
Knowledge of the organization and functions of departments and agencies which comprise county government
Strong analytical skills and ability to solve complex technical problems
Familiarity with software programs (Word, Excel, Access, Visio, PowerPoint, and statistical software packages like SAS, SPSS, or R) as well as an understanding of data storage principles and SQL is necessary
Ability to lead and motivate staff
Ability to develop and implement goals, objectives, policies, procedures, work standards and internal controls
Ability to analyze complex administrative and regulatory problems, evaluate alternatives and adopt effective courses of action
Ability to prepare clear and concise reports, correspondence and make effective presentations
Ability to exercise sound independent judgment within general policy guidelines
Ability to develop proposals and programs which respond to long- and short-range problems detected during analysis
Ability to develop proposals and programs which respond to long- and short-range problems detected during analysis
Ability to comprehend and analyze complex organizational and procedural problems involving work production, work flow, forms, records, systems and staff utilization
Ability to prepare and interpret a variety of reports, charts, layouts and other materials using computer and information services technology
Ability to enlist the cooperation of officials of various agencies to implement policy and procedural changes
Ability to present ideas effectively, both orally and in writing
Salary Range
$75,438.27 to $129,865.03/Annually
Mapp Biopharmaceutical, Inc.
San Diego, CA
Director, Quality Assurance GMP
Job #20-06A
Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases. The Early Research and Development Group (ER&DG) and the Advanced Research and Development Group (AR&DG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of robust portfolio with the CMC, Toxicology and Clinical development goals consistent with the product development objectives of Mapp. Partnering with the CMC, non-clinical, and clinical development functions at Mapp, the Director for QA-GMP is a hands-on, roll-up your sleeves-strategic thinking employee functioning as a key member of the Quality Assurance team. Additionally, the successful candidate partners with Principal Investigators and the program team to deliver on Mapp's portfolio.
Basic Qualifications:
BABS Degree in Science with 10+ Years of Quality Assurance Experience (GMP required and additional GLP and GCP experience is an advantage).
10+ Years of Biologics/mAb Product Development and/or commercial manufacturing experience in a small to mid-sized biopharmaceutical company
Direct experience in providing QA oversight for cGMP manufacturing operations
Knowledge of drug development regulations such as the GCP's, GMPs and GLPs
Travel required (up to 25% domestic and international)
Previous experience with auditing biological and parenteral manufacturing facilities
Experience overseeing GMPs (as a Sponsor) at third-party locations in a small or mid-sized Biotechnology company
Preferred Qualifications:
Previous technical CMC experience with monoclonal antibody Drug Substance and/or Drug Product development/commercialization
Experience across all phases of biologic drug development (Clinical phases 1 thru 4 of drug development) preferred
Understands patient dosing on a mg/kg basis
Experience in a technical or QA role for the oversight or execution of monoclonal antibody Drug Substance and Drug Product manufacture is an asset
Previous experience supporting Pre-approval Inspections is desirable
Experience working virtual preferred
Responsibilities
Mapp Focused
Provides quality oversight for all cGMP manufacturing and release
Partners with all CMC functional team members to assure the advancement of the integrated CMC program scope or work
Partners with Clinical to provide quality oversight for clinical Drug Product
Participates in Program team meetings and stakeholder meetings as required
Partners in the development of the Quality strategy for GMPs and ensures deployment as approved by senior management
Contributes to the development and maintenance of the global quality systems in line with current regulatory requirements, meeting US FDA and European requirements, and others as needed
Supports deployment and implementation of GxP practices, policies and procedures
Collaborates with, and supports Corporate leadership
Acts as point of contact with regulatory authorities regarding quality-related issues at third party GMP manufacturing sites.
Partners with the Mapp QA group to establish and provide support for the development and harmonization of quality standards and processes, compliant policies, procedures and specifications
Maintains good relationship with Regulatory bodies as well as FDA inspectors
Reports all critical and relevant Quality compliance matters to the Vice President of Quality Assurance
Ensures required Quality Assurance management and quality expertise is available and effective for operations
Ensures effective internal and external GxP audit programs are deployed and effective with focus on GMP manufacturing sites.
Ensures Quality Assurance review and approval/rejection of all GMP related procedures, documents and records
Ensures where appropriate, that all Mapp personnel training, investigation, deviation actions, critical documentation and audit actions are completed on time
Ensures escalation to the Vice President of Quality Assurance and leadership of all critical concerns from the site related to product quality issues encountered at sites and the partner's quality system
Ensures that QA team maintains appropriate independence in order to ensure that there is no conflict of interest between regulatory requirements and day-to-day operational priorities
Ensures risk management principles, the essence of ICHQ10 and a continuous improvement culture are built into QA ways of working
Assists in constructing annual GxP training
Authors Standard Operating Procedures (SOP's) related to GxP and other QMS related activities
May have limited supervisory duties
May be assigned limited GxP duties outside of GMPs
Partner Focused
Provides QA oversight for all cGMP activities at the GMP manufacturing locations, packaging and labeling sites including, but not limited to, review and approval of all manufacturing documentation (batch records, process flow documents etc. ) and final release of final material
Supports the evaluation/selection potential future contract manufacturing organizations (CMOs)
Provides quality input in technology transfers to CMOs
Ensures quality agreements are in place at CMOs to ensure adherence to regulatory requirements
Provides QA support for identification, risk assessments, action plans, remediation plans for any GMP manufacturing and test deviations and investigations
Functions as Lead Auditor for GMP manufacturing, test, packaging, labeling, and storage vendors and supports other functional vendor audits
Influences a strong quality and compliance culture at the partner and contractor sites
Acts as a SME on any GMP issue at the partner and clinical trial sites
Contributes as subject matter expert for matters relating to formal quality management and regulatory compliance at Mapp's partner sites in collaboration with the Vice President of Quality Assurance
Partners with key customers on Quality strategy and Quality system execution
Acts as primary contact for discussions on Quality matters with key customers and contractors
Acts as point of contact with regulatory authorities regarding quality-related issues at manufacturing sites
Deploys the quality and compliance strategy for to deliver strategic business objectives at partner site in conjunction with the applicable site
Ensures the existence/establishment of effective manufacturing control at partner sites
Ensures enforcement of investigation of non-conformances, as well as fraud
Ensures the manufacturing sites are "audit ready" and compliant at all times
Ensures where appropriate that all personnel training, investigation, deviation actions, critical documentation and audit actions at the manufacturing sites are completed on time
Writes audit plans and other documents
Maintains confidentiality
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment in San Diego, CA or may have the opportunity to work remotely. Willingness to travel domestically and internationally approximately 25% will be required for this position. Mapp wants you to join their team and invites you to apply.
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website. https://www.applicantpro.com/openings/mappbio/jobs/1464320-307440
Director, Quality Assurance GMP
Job #20-06A
Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases. The Early Research and Development Group (ER&DG) and the Advanced Research and Development Group (AR&DG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of robust portfolio with the CMC, Toxicology and Clinical development goals consistent with the product development objectives of Mapp. Partnering with the CMC, non-clinical, and clinical development functions at Mapp, the Director for QA-GMP is a hands-on, roll-up your sleeves-strategic thinking employee functioning as a key member of the Quality Assurance team. Additionally, the successful candidate partners with Principal Investigators and the program team to deliver on Mapp's portfolio.
Basic Qualifications:
BABS Degree in Science with 10+ Years of Quality Assurance Experience (GMP required and additional GLP and GCP experience is an advantage).
10+ Years of Biologics/mAb Product Development and/or commercial manufacturing experience in a small to mid-sized biopharmaceutical company
Direct experience in providing QA oversight for cGMP manufacturing operations
Knowledge of drug development regulations such as the GCP's, GMPs and GLPs
Travel required (up to 25% domestic and international)
Previous experience with auditing biological and parenteral manufacturing facilities
Experience overseeing GMPs (as a Sponsor) at third-party locations in a small or mid-sized Biotechnology company
Preferred Qualifications:
Previous technical CMC experience with monoclonal antibody Drug Substance and/or Drug Product development/commercialization
Experience across all phases of biologic drug development (Clinical phases 1 thru 4 of drug development) preferred
Understands patient dosing on a mg/kg basis
Experience in a technical or QA role for the oversight or execution of monoclonal antibody Drug Substance and Drug Product manufacture is an asset
Previous experience supporting Pre-approval Inspections is desirable
Experience working virtual preferred
Responsibilities
Mapp Focused
Provides quality oversight for all cGMP manufacturing and release
Partners with all CMC functional team members to assure the advancement of the integrated CMC program scope or work
Partners with Clinical to provide quality oversight for clinical Drug Product
Participates in Program team meetings and stakeholder meetings as required
Partners in the development of the Quality strategy for GMPs and ensures deployment as approved by senior management
Contributes to the development and maintenance of the global quality systems in line with current regulatory requirements, meeting US FDA and European requirements, and others as needed
Supports deployment and implementation of GxP practices, policies and procedures
Collaborates with, and supports Corporate leadership
Acts as point of contact with regulatory authorities regarding quality-related issues at third party GMP manufacturing sites.
Partners with the Mapp QA group to establish and provide support for the development and harmonization of quality standards and processes, compliant policies, procedures and specifications
Maintains good relationship with Regulatory bodies as well as FDA inspectors
Reports all critical and relevant Quality compliance matters to the Vice President of Quality Assurance
Ensures required Quality Assurance management and quality expertise is available and effective for operations
Ensures effective internal and external GxP audit programs are deployed and effective with focus on GMP manufacturing sites.
Ensures Quality Assurance review and approval/rejection of all GMP related procedures, documents and records
Ensures where appropriate, that all Mapp personnel training, investigation, deviation actions, critical documentation and audit actions are completed on time
Ensures escalation to the Vice President of Quality Assurance and leadership of all critical concerns from the site related to product quality issues encountered at sites and the partner's quality system
Ensures that QA team maintains appropriate independence in order to ensure that there is no conflict of interest between regulatory requirements and day-to-day operational priorities
Ensures risk management principles, the essence of ICHQ10 and a continuous improvement culture are built into QA ways of working
Assists in constructing annual GxP training
Authors Standard Operating Procedures (SOP's) related to GxP and other QMS related activities
May have limited supervisory duties
May be assigned limited GxP duties outside of GMPs
Partner Focused
Provides QA oversight for all cGMP activities at the GMP manufacturing locations, packaging and labeling sites including, but not limited to, review and approval of all manufacturing documentation (batch records, process flow documents etc. ) and final release of final material
Supports the evaluation/selection potential future contract manufacturing organizations (CMOs)
Provides quality input in technology transfers to CMOs
Ensures quality agreements are in place at CMOs to ensure adherence to regulatory requirements
Provides QA support for identification, risk assessments, action plans, remediation plans for any GMP manufacturing and test deviations and investigations
Functions as Lead Auditor for GMP manufacturing, test, packaging, labeling, and storage vendors and supports other functional vendor audits
Influences a strong quality and compliance culture at the partner and contractor sites
Acts as a SME on any GMP issue at the partner and clinical trial sites
Contributes as subject matter expert for matters relating to formal quality management and regulatory compliance at Mapp's partner sites in collaboration with the Vice President of Quality Assurance
Partners with key customers on Quality strategy and Quality system execution
Acts as primary contact for discussions on Quality matters with key customers and contractors
Acts as point of contact with regulatory authorities regarding quality-related issues at manufacturing sites
Deploys the quality and compliance strategy for to deliver strategic business objectives at partner site in conjunction with the applicable site
Ensures the existence/establishment of effective manufacturing control at partner sites
Ensures enforcement of investigation of non-conformances, as well as fraud
Ensures the manufacturing sites are "audit ready" and compliant at all times
Ensures where appropriate that all personnel training, investigation, deviation actions, critical documentation and audit actions at the manufacturing sites are completed on time
Writes audit plans and other documents
Maintains confidentiality
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment in San Diego, CA or may have the opportunity to work remotely. Willingness to travel domestically and internationally approximately 25% will be required for this position. Mapp wants you to join their team and invites you to apply.
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website. https://www.applicantpro.com/openings/mappbio/jobs/1464320-307440