QA Director - Gene Therapy Experience
Duration: 6-12 Months (Intent to Convert)
Location: Remote/Princeton, NJ
Travel: Approximately 25%
This individual will provide guidance on the enhancement of Quality Management Systems and Risk Management Plans to support product release for clinical studies. S/he will partner with all other functional area heads to ensure alignment of strategic and operational goals.
- Act as Quality Lead for Gene Therapy activities conducted at CDMO's, CRO's and Contract Laboratories. Oversee all CMC activities (including Tech Transfer).
- Ensure all required assessment and testing is carried out to support Quality approval or rejection, as appropriate, for cell banks, intermediates, bulk and finished drug product.
- In collaboration with the Quality teams at CDMO, ensure all deviations/change controls from established procedures are appropriately documented and investigated to determine and address root cause.
- Support the enhancement of existing Quality Systems to assure growing Development, Manufacturing and Clinical oversight of the Gene therapy programs.
- Create risk based, compliance and business-aligned strategies for phase appropriate batch release operations.
- Communicate effectively with Senior Management on project plans, compliance risks and mitigations (including escalation of issues).
- Perform QA review of Master and Executed Batch Records
- Work closely with Regulatory to respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions.
- Support the Regulatory strategy of filing for approval of IND, IMPD, CTA, BLA. Help to author relevant sections.
- May interact with regulators.
- May participate in/manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections.
- Minimum B.S. degree, in chemistry, molecular biology, biochemistry or microbiology. Advanced degree preferred.
- 10-15 years of experience in biopharmaceutical based GMP manufacturing QA-Ops, including direct experience in cell culture, downstream & upstream processes, aseptic fill/finish, testing of drug substance and drug product preferred. Experience with viral gene therapies a must.
- External Manufacturing/CMO compliance interaction
- Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections.
- Direct experience reviewing and/or authoring CMC sections of regulatory filings and partnering with operations on product/facility related investigations and deviations.
- Domestic and possible international travel required (25%).
Sthree US is acting as an Employment Business in relation to this vacancy.