QA Director - Gene Therapy Experience

Location: Princeton, New Jersey, United States
Salary: competitive
Job Type: Contract
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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.

Responsibilities:

  • 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.

Qualifications:

  • 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.

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