Senior Manager, GMP Vendor Quality

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 Crinetics policies, 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. 

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Directly support the Supply Chain QA Director, 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 safety, 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, Quality Risk Management, 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

Education and Experience:

Required:

• Bachelor’s degree with a 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

• Knowledge of Quality Systems, Manufacturing, and Analytical Control Strategies

• Experience with product complaints, 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 the ability to manage multiple projects and execute in adherence to timelines

• Software knowledge:  MS Office, DocuSign, electronic QMS systems

Preferred:

• Advanced degree in a scientific or technical discipline or an MBA

• Solid dosage and drug substance experience is preferred, however, experience in other dosage forms with relevant experience is acceptable.

• Prior experience with Veeva QMS systems (Quality Vault)

• GMP Lead Auditor Certification

Physical Demands and Work Environment:

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of th