Director, Quality Assurance - GXP
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, and in support of biodefense programs.
The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio with the CMC, Preclinical/Nonclinical (together, "Nonclinical"), Regulatory and Clinical development goals consistent with the product development objectives of Mapp.
The Director of Quality Assurance - GxP an individual contributor who is a strategic thinking employee functioning as a key member of the Quality Assurance team who also partners with the CMC, non-clinical, and clinical development functions. Additionally, the successful candidate partners with Principal Investigators and the program teams to deliver on Mapp's portfolio.
- BS/BA Degree in a related Science; MS Degree in related Science preferred
- 10+ Years of Development experience in a regulated pharmaceutical industry, preferably within a Biologics/mAb Product Development environment
- 10+ Years of experience in a QA-GxP role or a role that interacts with Quality Assurance; GCP and GMP
- Possesses the knowledge to act as a SME on any QA-GMP, QA-GLP, and QA-GCP issues
- Experience in a technical or QA role for the oversight or execution of monoclonal antibody Drug Substance and Drug Product manufacture
- Direct experience in providing QA oversight for cGMP manufacturing operations.
- Knowledge of drug development regulations such as the GCPs, GMPs and GLPs
- Willingness to travel required (up to 25% domestic and international)
- Previous technical CMC experience with large molecule (preferably monoclonal antibody) Drug Substance and/or Drug Product development/commercialization
- Previous experience with auditing biological and parenteral manufacturing facilities, laboratories that perform regulated activities, and/or clinical sites
- Experience overseeing GxPs (as a Sponsor) at third-party locations in a small or mid-sized Biotechnology company
- 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
- Previous experience supporting Pre-approval Inspections is desirable
- Experience working virtual preferred
- Provides quality oversight for cGMP manufacturing and batch release, and GCP activities
- Partners with all CMC functional team members to assure the advancement of the integrated CMC program scope or work
- Reviews and approves GxP protocols, reports, Standard Operating Procedures, documentation, and any other relevant documents to ensure GxP compliance
- Assists the Clinical team with GCP compliance for clinical studies and may assist the Nonclinical team with GLP compliance for regulated activities
- Participates in Program team meetings and stakeholder meetings as required
- Partners in the development of the GxP Quality strategy in line with current regulatory requirements, meeting US FDA, European, and ICH requirements, and others as needed, and ensures deployment as approved by senior management
- Acts as point of contact with regulatory authorities regarding quality-related issues at third party GMP manufacturing sites.
- Reports all critical and relevant Quality compliance matters to the Head of Quality Assurance
- Ensures, where appropriate, that all Mapp personnel training, investigation, deviation actions, critical documentation and audit actions are completed on time
- Ensures escalation to the Head 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 risk management principles, the essence of ICHQ10, and a continuous improvement culture are built into QA ways of working
- Authors Mapp Standard Operating Procedures (SOP's) related to GxP and other Mapp QMS related activities
- Acts as a SME on any QA-GMP, QA-GLP, and QA-GCP issues at the partner sites and internally for program teams
- 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
- Provides QA oversight for all GCP activities at the CRO location(s) and works closely with the Mapp Clinical team to ensure appropriate compliance.
- Ensures quality agreements are in place at CMOs and CROs 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 at partner sites
- Functions as Lead Auditor for GMP manufacturing, test, packaging, labeling, and storage vendors and supports other functional vendor audits, and Lead Auditor for GCP activities at partner CROs
- Influences a strong quality and compliance culture at the partner and contractor 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 Head of Quality Assurance
- Acts as point of contact with regulatory authorities regarding quality-related issues at manufacturing sites
- Deploys the quality and compliance strategy 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 partner 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
- Maintains confidentiality
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. This is a fully remote position working outside of the State of Colorado. Willingness to Travel (1x/Month = Domestic Travel + 2x/Year = International Travel) will be required for this position.
Mapp wants you to join their team and invites you to apply by submitting your information through .
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Qualified 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.