Director, Quality Operations

Director, Quality Operations (Clinical & Commercial)

Responsibilities
- Oversee quality for starting materials, intermediates, drug substance/drug product manufacturing, and packaging/labeling.
- Review/approve quality-impacting specifications; oversee master batch records and process/method validation protocols and technical documents across development to commercialization.
- Disposition clinical and commercial batches.
- Ensure GMP compliance for CAPA, change control, deviations, and related manufacturing/testing activities.
- Support and collaborate with internal and external partners impacting quality operations.
- Conduct risk assessments; implement appropriate quality/process controls.
- Support vendor qualification and monitor vendor performance.
- Communicate potential compliance issues promptly to management.
- Participate in internal/external project team meetings.
- Maintain SOPs/policies and Quality Agreements; establish/review/manage Quality Agreements.
- Ensure external parties are inspection-ready for GMP audits/inspections (FDA and other regulators); support regulatory submissions with required documentation.
- Support site preparation for inspections (personnel prep/training) and CMC updates for regulatory/quality documents.
- Drive continuous improvement; develop operation metrics and corrective actions; promote a strong quality culture.

Qualifications / Skills
- 10+ years in Quality Assurance and GMP compliance (pharma/biotech).
- Extensive outsourced manufacturing oversight (CMOs/external providers).
- Experience with small molecules and biologics (ideally ADCs).
- Senior experience leading global regulatory inspections and managing outcomes.
- Experience from development-stage through commercial operations.
- Proven CAPA, audit, and continuous improvement leadership.
- Travel up to 20%.
- Deep knowledge of GMP/GDP, inspection readiness, risk-based compliance, recalls, and quality governance.