Senior Manager, GMP Vendor Quality

at  CRINETICS PHARMACEUTICALS

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.

POSITION SUMMARY:

The Senior Manager GMP Vendor Quality will be primarily responsible for the oversight of GMP Vendor performance, overseeing the GMP Vendor Assurance program and assuring compliance with FDA, European, and other country-specific regulations. This position will be responsible for developing collaborative and productive partnerships internally, as well as externally with global contract organizations and strategic partners. This individual will be an integral part of the company’s effort to develop small molecule therapeutics for rare endocrine disorders and endocrine-related tumors through support of GMP outsourced operations.

EDUCATION AND EXPERIENCE:

Required:

• Bachelor’s degree with scientific or technical discipline
• 8 years of relevant experience in a regulated, GMP environment with 5 years of leadership, continuous improvement and/or project management experience
• Demonstrated knowledge of FDA/EMA/ICH standards and regulations
• Experience working with Contract Management Organizations and/or auditing CMOs
• Experience with product complaint, stock recovery, recall and field alert processes
• Ability to effectively organize, prioritize and work in a fast-paced environment
• Ability to function individually and in a team environment
• Strong project management skills with ability to manage multiple projects and execute in adherence to timelines
• Software knowledge: MS Office, Docusign, electronic QMS systems

Preferred:

• Solid dosage or drug substance experience is preferred, however, experience in other dosage forms with relevant experience is acceptable.
• Prior experience with Veeva QMS systems (Quality vault)

These may include but are not limited to:

• Directly support the GMP QA Director and Senior Director with GMP Vendor lifecycle management through vendor selection, on-boarding new vendors and requalification and risk management
• Coordinate vendor audit scheduling and adherence to deliverable timings
• Oversee contracts and consultant auditors for support of GMP Vendor audits and multi-country GMP inspection readiness activities
• Coordinate CMO APQR/APR scheduling, development of Crinetics executive summary and adherence to deliverable timings
• Oversight for internal GMP Quality Events (Complaints, Deviations, CAPAs) processes with appropriate escalation of Major and Critical events with potential to impact patient safely, product quality or supply delays
• Serve as the project manager for assigned GMP QA process improvement initiatives, projects and teams, including Change Control Review Board, GMP QMR sections and others to be defined
• Represent QA in internal and external team meetings
• Perform, review and/or approve impact assessments and risk assessments
• Write and review standard operating procedures
• Perform vendor audits as assigned and support vendor lifecycle activities
• Other duties as assigned