Sr. Manager, Drug Product Quality Assurance Operations

Senior Manager, Quality Assurance Operations

Responsibilities
- Lead quality operations for clinical and commercial sterile drug product related to CMOs, including oversight of contract manufacturing and contract labs to ensure a robust and compliant quality program.
- Oversee drug product batch record review and disposition process.
- Establish operational objectives, reviewed by senior management, and delegate assignments to subordinates.
- Develop, modify, and execute policies affecting immediate operations (and potentially company-wide).
- Supervise costs, methods, and staffing (may supervise subordinate supervisors).
- Work on objectives with major impact on the unit and organization.
- Resolve issues requiring in-depth knowledge of organizational objectives and current business trends.
- Manage QA personnel responsible for sterile injectable drug product batch record review and lot disposition.
- Coordinate cross-functional deliverables to support product release.
- Oversee commercial and clinical drug product manufacturing contract vendors (CMO/CTL), ensuring obligations are met per quality technical agreements and support CMO/CTL quality systems.
- Lead investigations (deviations, laboratory investigations, CAPA, etc.) related to quality oversight, OOS, product complaints, field alerts, and/or recalls.
- Navigate challenging vendor situations and relationships.
- Collaborate within QA and cross-functionally on applicable projects.

Qualifications
- BA/BS degree in a related field.
- 8+ years related experience.
- Proficient in Microsoft suite.
- Technical knowledge of pharmaceutical manufacturing and laboratory operations.

Application Instructions
- Candidates must be authorized to work in the U.S.