Associate Director, GMP Quality Assurance Operations

Responsibilities:
- Lead and execute GMP QA activities for development programs (master cell bank, working cell bank, drug substance, drug product/finished goods) aligned with the Quality System.
- Support batch record review, disposition, and release for clinical materials; support QP/RP interactions where applicable.
- Provide hands-on QA oversight of CDMOs and key suppliers (qualifications, audits, QTA, issue management, performance monitoring).
- Act as primary QA point of contact for tech transfer, scale-up, process validation/qualification, and analytical method validation/transfer.
- Execute and support GMP quality systems (deviations, investigations, CAPA, change control, batch review, CPV, OOS/OOT, stability) with timely compliant closure.
- Partner with CMC, Technical Operations, Analytical Sciences, Quality Control, Supply Chain, and Regulatory teams to integrate quality oversight into program execution.
- Support review of CMC sections for INDs, IMPDs, BLAs, and MAAs; support responses to health authority questions.
- Conduct GMP quality risk management (identify/assess/escalate risks; propose mitigations).
- Support labeling/packaging and temperature excursions; manage QP declarations/certification and QP release coordination as applicable.
- Track and report GMP quality metrics/trends; support continuous improvement.
- Provide quality oversight/approval for GMP technical transfer activities (clinical-to-commercial, site-to-site, CMO/CDMO) for drug substance and drug product.
- Ensure tech transfer strategies/protocols/reports/control plans meet GMP, data integrity, and regulatory expectations.
- Lead as Quality on the Tech Transfer Team; review/approve CPPs, CQAs, control strategies, acceptance criteria; confirm readiness for PPQ/conformance and launch.
- Approve tech transfer GMP documentation (protocols/final reports, process validation, risk assessments, change controls); ensure alignment with regulatory filings/submissions.
- Participate in regulatory inspections and partner audits; host authority/customer audits.

Qualifications:
- Bachelor’s in a scientific discipline (advanced degree preferred) and at least 8 years progressive GMP QA experience in biotech/pharmaceutical development.
- Hands-on biologics manufacturing experience (drug substance and drug product).
- Experience with GMP technical transfer activities (late-stage transfers and CDMO technology transfers).
- Working knowledge of global GMP regulations/guidance (FDA, EMA, ICH) for clinical-stage biologics.
- Proven QA oversight experience for internal early-stage manufacturing and CDMOs/external QC labs (audits, investigations, change management, issue resolution).
- Solid understanding of validation principles and batch release processes.
- Experience working with multi-geography teams.
- Strong attention to detail; able to work independently and with multidisciplinary teams and external partners.
- Strong commitment to compliance and ethical standards.
- Proficient with Microsoft Office suite.

Required/Preferred Skills & Experience:
- GMP QA leadership, quality systems execution, and inspection readiness.
- Tech transfer/validation/analytical method transfer governance.
- Risk management and cross-functional collaboration.

Compensation:
- Pay range: $160,000–$200,000.

Application instructions:
- None provided.