Sr. Manager, Drug Product Quality Assurance Operations
About The Position
The Senior Manager, Quality Assurance Operations will lead the quality operations for clinical and commercial sterile drug product related to CMOs. This includes oversight of contract manufacturing and contract labs to ensure a robust and compliant quality program. The position will oversee the drug product batch record review and disposition process. The position will encompass various tasks including, but not limited to the following: • Establishes operational objectives, which are reviewed by senior management, and delegates assignments to subordinates. • Involved in developing, modifying and executing company policies that affect immediate operations, and may also have company-wide effect. • Conducts supervision in terms of costs, methods, and staffing. In some instances, this manager may have subordinate supervisors. • Works on objectives that have major impact on unit and the organization • Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives and current business trends.
Requirements
- BA/BS degree in a related field
- 8 + years related experience
- Proficient in Microsoft suite
- Must have technical knowledge of Pharmaceutical manufacturing and laboratory operations.
Responsibilities
- Manage team of QA personnel responsible for sterile injectable drug product batch record review and lot disposition.
- Coordinate cross-functional deliverables to support product release.
- Oversight of commercial and clinical drug product manufacturing contract vendors (CMO and CTL), includes ensuring obligations are met per quality technical agreements and support of CMO and CTL quality systems.
- Lead Investigation activities (Deviations, Laboratory Investigations, CAPA activities, etc.) associated with general quality oversight, OOS, product complaints, field alerts and/or recalls
- Navigate challenging situations and relationships with vendors.
- Collaborate within QA and cross functionally on projects as applicable.
Benefits
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
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What This Job Offers
Job Type
Full-time
Career Level
Manager
