Director of Quality Assurance / Quality Control (QA/QC)
Location: Bristol, PA
The Quality Director will lead Abzena’s quality functions while promoting a culture of quality by collaborating across all departments and levels of management to accomplish company objectives. The Quality Director will oversee all quality activities supporting the development and manufacture of clients’ early-phase GMP novel cytotoxic and antibody drug conjugate (ADC) compounds. The Quality Director will apply practical knowledge of phase-appropriate GMPs in the product development life cycle, including but not limited to: analytical and process development, qualification and validation, technology transfers, establishment of drug substance release and stability specifications, and generation of CMC submissions. Experience working in GMP regulated environment is essential.
This position is deputy to the Sr. Vice President of Global Quality for Abzena and will be responsible for the management of Quality Assurance and Quality Control programs at our Bristol, PA site as well as supervising the employees performing this work.
- All duties are performed independently with minimal supervision and oversight. Incumbent is considered expert in quality systems.
- Author, review and approve SOPs, protocols, reports, specifications and other quality and regulated records for accuracy and compliance with all applicable regulations, international standards.
- Oversee GMP Quality Management Systems, Batch Release and QC testing activities for compliance to internal procedures and FDA, EU, ICH, and other regulatory expectations and requirements
- Develop and implement phase-appropriate requirements for product development, manufacturing and testing activities.
- Lead the technical transfer, verification and/or qualification of internal test methods to QC lab for release of raw materials, in-process materials, intermediates, APIs and finished products
- Manage the implementation, qualification, validation (when applicable) and transfer of client’s product specific methods. Assist in timely writing, editing and review of documents such as Standard Test Methods, Technical Reports and QC SOPs
- Works closely with Manufacturing team to ensure proper preparation and submission of comprehensive manufacturing documentation to the clients
- Work closely with Manufacturing and Testing groups to coordinate GMP related activities with respect to timelines and compliance.
- Oversee review and approval of analytical method validation reports for compliance to internal Quality standards and regulatory guidance’s.
- Lead and facilitate thorough GMP investigations for process deviations, out of specification test results, Out of Tolerance events and corrective actions.
- Perform problem solving for issues pertaining to GMP production applying phase appropriate GMP expectations.
- Oversee batch review activities and disposition of Drug Substance lots.
- Oversee customer product stability programs including generation of stability protocol, execution of stability testing, stability analysis and final reporting of stability data.
- Review and provide quality input for CMC sections of client’s IND and IMPD submissions for Drug Substance, Drug Products and stability studies as requested.
- Provide Quality input for failure analysis, problem solving, and risk assessment and mitigation activities related to the qualification and validation of the GMP facility and equipment
- Collaboratively work with client to establish client-specific Drug Substance product specifications in accordance with regulatory expectations.
- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results with a customer driven focus
Qualifications/Skills Required Essential:
- Bachelor’s degree in a relevant discipline (chemistry, biological sciences, pharmacy or equivalent)
- Broad knowledge of drug development
- Minimum ten (10) years of experience in the pharmaceutical industry within a Quality role
- At least six (6) years of experience leading a quality organization Expert knowledge of GMP regulations, good documentation practices, cGMP, 21CFR, USP and other applicable regulations, standards and guidance.
- Demonstrated ability to successfully interface and provide guidance to multi-disciplined teams from project inception through project completion with respect to FDA requirements, agency and vendor audits, corrective actions, and complaint management.
- Extremely detail oriented with strong analytical, written and verbal communication skills.
- Experience in hiring and staffing a growing organization and mentoring high potential individuals.
- Must be familiar with Microsoft Office applications.
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity
- Demonstrate sense of urgency; ability to recognize time sensitivity
- Flexible and adaptable style with an eagerness to take on challenges
- Problem solver who not only identifies issues but leads efforts to resolve them
- Experience of working within both biologics and small-molecule manufacturing Quality environments
- Experience of working with bioconjugates
- Skill in aseptic processing experience with respect to drug product formulation would be an advantage