Senior Manager, GMP Investigational Quality

The Role:

Responsible for GMP Quality oversight and lot review/release activities supporting early and late-stage phase investigational programs, including drug substance, drug product, and clinical finished goods manufactured, packaged, labeled, stored, and distributed by Contract Manufacturing Organizations (CMOs) and other external partners. Ensure compliance with cGMPs, Syndax Quality Systems, and applicable regulatory requirements.

• Support GMP quality oversight for early phase programs (review/approval of master batch records, executed batch records, CoAs, specifications, method qualification protocols/reports, and source documentation).
• Support clinical finished goods release (packaging/labeling records, label proofs, expiry/retest, temperature excursion documentation, product release/QP release support).
• Coordinate with external manufacturers, CDMOs, contract labs, and packaging/labeling vendors and internal partners.
• Manage deviations, investigations, CAPAs, change controls, OOS/OOT events, complaints, and other quality events (focus on patient safety, data integrity, and supply continuity).
• Lead quality investigations; drive root cause, CAPA development, and effectiveness verification.
• Partner with CMC, Analytical Development, Supply Chain, Clinical Operations, Regulatory Affairs, and external partners to identify GMP risks and resolve quality issues.
• Identify/mitigate GMP compliance risks, quality system gaps, and process improvement opportunities.
• Author/review/approve GMP quality documents (deviations, change controls, CAPAs, SOPs, quality agreements as applicable).
• Maintain clear communication of quality risks, open issues, and release readiness.

• BS in a scientific field (required).
• 5+ years in pharma/biotech with GMP Quality experience supporting CMOs and clinical-stage development.
• Early phase GMP oversight experience for drug substance/drug product/clinical finished goods.
• Experience reviewing/approving GMP documentation (MBRs/EBRs, clinical packaging/labeling records, CoAs, method qualification).
• Experience with clinical labeling/packaging, release, expiry/retest, temperature excursions, and QP release.
• Experience managing deviations/investigations/CAPAs/OOS-OOT/complaints and product impact assessments.
• Cross-functional experience (CMC, Analytical Development, Supply Chain, Clinical Operations, Regulatory Affairs, vendors).
• Strong technical writing; clear verbal/written communication.
• Judgment, project management, and ability to manage multiple priorities in fast-paced outsourced/hybrid environments.