Primarily responsible for ensuring the successful and timely release of GMP clinical supplies by providing direction and oversight of the overall manufacturing, testing and release processes of cell and gene therapy products, including critical raw material, in-process material, drug substance to drug product to finished product.
- Serve as the QA point of contact in CMC and Supply Chain meetings and direct QA functional areas to facilitate the approval of therapeutics product to clinical trials to meet project timelines
- Support in-licensing, out-sourcing, and external collaboration activities
- Support the preparation of regulatory inspections and internal audits, and represents GMP Quality in inspections and audits.
- Ensure establishment of material and product specifications including QC analytics and risk identifications.
- Interact and influence decisions of the various R&D Directors and Vice Presidents as well as external customers and mentor Quality Engineers
- Serve as a subject matter expert and provide consultation & training on QA specific items to internal and cross-functional groups
- Lead complex global cross-functional process improvement along with SME.
- Work on unusually complex technical problems and provide solutions that are highly innovative and ingenious; resolve project team issues with minimal oversight
- Review and approve manufacturing batch records, analytical data/reports, and other GMP batch documents. Conduct batch release of cell and gene therapy products.
- Participate and manage investigations and support OOS, deviations, CAPA and Change Management/Change Controls.
- Ensure suitable quality agreements or quality aspects of contracts are in place between R&D and third-party manufacturers, third party laboratories, other service providers and other sites
- Provide management of clinical supply product actions and recalls
- Bachelor's degree or equivalent experience is required, typically in life sciences, engineering
- Minimum 6+ years of biopharma industry experience in Quality Assurance, drug development or other healthcare related field; less experienced considered with advanced degree (such as in Molecular or Cell Biology, Genetics, or Biochemistry, etc)
- Experience with recombinant AAV vectors, lentiviral vectors, and cell therapy products is strongly preferred
- Strong working knowledge of cGMP, FDA and EMA GMP regulation and ICH guidance documents.
- Prior working experience in a GMP environment and/or with CDMO(s) is preferred.
- Broad understanding of pharmaceutical manufacturing processes including manufacturing process for viral and non-viral based gene therapy products, their release assays, analytical sciences, and worldwide quality requirements for GMP is required.
- Knowledge of regulatory compliance requirements should include historical perspectives and current trends of the regulatory agencies, especially for cell and gene therapies as they apply to the clinical manufacturing processes.
- Good communications skills
- Must have leadership skills and have been seen to take a position on quality issues and standards, and must be capable of clearly and logically justifying such positions.
- Other competencies are required, e.g., making difficult decisions, relationship-building, influencing, fostering teamwork, knowledge of the business and sound judgment
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)
Travel: Yes, 5 % of the Time
Job Type: Experienced