GeneCoda has been engaged to identify and evaluate candidates for a Senior Director / Director of Biologics Quality Assurance to be located in the Research Triangle Park, NC marketplace.
About Our Client:
Our client is an innovative, clinical stage biopharmaceutical company developing medically important pharmaceutical products to treat B-cell diseases in both hematology and autoimmune therapeutic areas with unmet needs.
The Senior Director / Director of Biologics QA is responsible for quality oversight of biologics clinical development programs and future commercial manufacturing. Our client’s products span early to late-stage clinical development and include both solid oral and liquid injectable dosage forms manufactured by various contract manufacturers.
- Demonstrate high level involvement in continuous improvement of quality assurance philosophy and practices to ensure high standards.
- Manage QA resources to support biologics CMC
- Review and approve controlled documents, including master batch records, analytical methods, specifications, analytical and process validation protocols, and final reports.
- Review lot-related deviations, CAPAs, and change controls; perform lot disposition.
- Work with Quality Systems and CMC team to ensure that quality and technical documentation is delivered to the internal archiving system.
- Evaluate and manage potential quality impact of product complaints as reported and as a result of trends.
- Plan, conduct or facilitate supplier qualification audits and due diligence CDMO site visits, and direct Quality "Person-in-Plant" execution, as needed.
- In collaboration with Quality Systems team, negotiate Quality agreements with CDMO’s
- Support inspection preparedness activities internally and with CDMO’s.
- Provide guidance, advice, and support for GMP operations Quality Compliance As a member of the CMC team, participate in the agreed projects and activities designed to support Quality aspects of CMC objectives.
- Contribute to development of Quality Systems as relevant, such as creation of SOPs related to batch release, product complaints or other topics.
- Participate in developing, reporting, reviewing, and trending of cGMP-related Quality Metrics such as Key Performance Indicators (KPIs) in support of the QMS.
- Travel approximately 10-20% of the time (domestic and international); the frequency of travel may increase for short durations to meet critical business needs.
Education: Bachelor of Science degree in a scientific discipline, technology, engineering, or related field. An advanced, post-graduate degree is desirable.
Experience and Qualifications:
- 10 or more years of experience in GMP Quality or Manufacturing in the biopharma / biologics/ pharmaceutical industry; experience in biologics is required.
- A thorough knowledge of GMP regulations; direct interaction with FDA, EMA or other regulatory agencies during regulatory inspections is preferred.
- Experience supporting clinical phase through commercial manufacturing.
- Experience in tech transfers and outsourcing to contract manufacturing.
- Ability to both strategize (i.e., see the ‘big picture’) and provide attention-to-detail and hands-on support.
- Ability to influence and work effectively across the entire organization from executive leadership, department, and business function heads to cross-functional project teams.
- Strong collaborative skills. Team player mentality.
- Effective decision-making and problem-solving.
- Ability to troubleshoot, identify root causes and systematically resolve problems.
- Ability to prioritize, organize and manage multiple projects simultaneously.
- Excellent interpersonal skills.
- Excellent verbal and written communication skills.
GeneCoda refers qualified applicants for all jobs without regard to race, color, religion, creed, age, sex, disability, marital status, national origin, pregnancy, family medical history or genetic information, sexual orientation or preference, Vietnam Era Veteran status or other protected military status or any other status protected by federal, state, or local law.