Operations QA Manager – Commercial
| Company | Exelixis |
|---|---|
| Location | Alameda, CA, USA |
| Salary | $112000 – $158000 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- BS/BA degree in related discipline and a minimum of 7 years of related experience; or,
- MS/MA degree in related discipline and a minimum of 5 years of related experience; or,
- PhD in related discipline and 0 or more years of related experience; or,
- Equivalent combination of education and experience.
- Experience in the biotech or pharmaceutical industry is required.
- Working knowledge of the commercial and clinical manufacturing and quality processes, including US and EU regulations affecting the pharmaceutical industry.
- Has extensive experience in a virtual manufacturing environment or relevant industry/profession.
- Attention to detail when utilizing PC or reviewing documents and editing/proof-reading documents.
- Must be proficient in Word, Excel and PowerPoint.
Responsibilities
- Develops, establishes and maintains the QA programs, policies, and procedures to ensure GMP compliance of commercial and clinical trial material.
- Performs record review, and disposition activities for commercial and clinical trial material including conducting the comprehensive QA assessment.
- Coordinates investigations with vendors and interdepartmental teams to resolve potential product quality issues.
- Oversees the generation, review and/or approval of internal and external documents used in GMP activities.
- Provides support to the QA Partner to manage vendors, contract facilities and joint development collaborators for contracts, validation activities, change management and other QA issues.
- Supports the implementation of other quality systems, including departmental and corporate procedures, to ensure compliance with GMPs.
- Understands regulatory agency policies and guidance as it pertains to QA issues.
- Assists in monitoring current and proposed quality and scientific issues and advises supervisor on events for Exelixis.
- Provides support as needed for the review various quality review/approval documents such as, but not limited to, manufacturing, testing and labeling/packaging batch records, and CMC documents submitted to regulatory agencies.
- Authors work instructions and standard operating procedures.
- Drives for results.
Preferred Qualifications
- Experience in CMO oversight is preferred.
- Small molecule technical knowledge, oral solid dosage form and biologics preferred.
- Familiarity with serialization is desired.