Sr. Director, GMP Quality Operations
Job Title: Sr. Director, GMP Quality Operations
Company: Precision Medicine
Location: San Francisco, CA
Brio Resource Group is a Life Sciences Executive Search Firm committed to providing rare talent on an exclusive search basis to the Biopharma, Pharma, Device and CRO industries. We work on behalf of organizations that value true talent acquisition partners and specialize in supporting emerging Biopharma companies offering life-changing therapies. Our many years of experience, subject matter expertise, comprehensive search process and genuine passion to deliver rare talent defines Brio.
We work with a range of life sciences organizations across multiple industry disciplines, with one of our strongest portfolio’s in Clinical Operations. With US offices strategically located on the east coast (DC Metro) and west coast (San Diego) we connect rare life sciences talent with emerging companies nationwide.
Position Overview: Sr. Director, GMP Quality Operations
As a Senior Director GMP Quality Operations, you will be reporting to the Vice President of Quality. This role will be responsible for providing operational oversight for the CMC team, managing the implementation of the Quality Systems and GMP pillars, as well as supporting the VP of Quality in building the organizations strategy and vision.
- Support the research and clinical teams ensuring oversight of manufacturing operations as well as working with the CMC leadership
- Function as the technical subject matter quality expert for all matter related to GMP regulations and guidelines in relation to testing manufacturing, and analytical controls
- Implement GMP activities as necessary by internal procedures as well as the application of the regulatory requirements
- Support and Lead activities related to external quality in regards to development of process and analytical methods, deviations/investigations, lot dispositions, supplier and contract manufacturing selection, and tech transfers
- Represent Quality on Health Authority Inspections, suppliers and CDMO operational meetings, project teams, and QA to QA meetings
Position Requirements: Bachelor’s Degree in Biology Chemistry, Chemical Engineering or related fields
- 15+ years GMP Quality Assurance experience
- Strong understanding small molecule manufacturing along with direct experience in solid oral dosage forms
- Able to make sound and timely quality decisions when faced with complex compliance, technical, supply, and regulatory considerations
- Strong knowledge of Quality Management Systems as well as experience with implementing and managing quality systems within the pharmaceutical industry
- Knowledge of FDA practices and regulations and ICH guidance and global health authority practices and regulations
We welcome the opportunity to provide a full job description upon resume review.
How to Apply:
In order to be considered for the above opportunity, simply apply via LinkedIn and include your CV.
We respond to applicants who meet our position requirements, but suggest submitting your resume for future consideration for our expanding list of new opportunities surfacing daily within our Biopharma network. We have a strict honor code at Brio respecting your confidentiality and we only share your information with your consent.
Brio Resource Group, LLC considers all applicants without regard to race, color, religion, sex, national origin, age, mental or physical disabilities, or any other similarly protected status.