Director, Quality Assurance GMP
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.
- 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
- 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
- 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
- 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.