Associate Director, Quality Assurance GCP

Crinetics is a pharmaceutical company based in San Diego, California that develops much-needed therapies for people with rare endocrine diseases. 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 robust pipeline across preclinical and clinical development.

We are driven by science with a patient-centric and team-oriented culture. 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. Come join our team as we transform the lives of others.
*
* Position Summary:

** The Associate Director, Quality Assurance GCP supports the Good Clinical Practice (GCP) Quality Assurance (QA) function and performs day-to-day GCP QA operations. She/he will execute and/or ensure proper oversight of GCP QA activities, perform external and internal audits, support clinical phase 1 to phase 4 study team activities, review documents, support regulatory inspections, and enhance GCP QA infrastructure development. In alignment with updated ICH E6(R3) expectations, the Associate Director emphasizes flexible, proportionate, and risk-based quality oversight, maintains inspection readiness, and leads proactive, data-driven quality management via continuous identification and mitigation of quality risks.
** Essential Job Functions and Responsibilities:
** These may include but are not limited to:
* Manage or perform clinical site, internal, TMF, GCP, and GLP vendor audits.
* Generate and/or review GCP and GLP QA audit plans and schedules, tailoring scope and depth to study/process risk and complexity.
* Generate and/or review and approve audit trend reports across programs to identify systemic issues and drive preventive actions.
* Communicate, address, and prevent identified GCP compliance issues and trends.
* Develop and manage audit programs.
* Represent QA at program-wide (eg, Clinical Development Team or CRO) meetings and provide GCP guidance and feedback.
* Serve as point of escalation for GCP compliance issues identified by clinical study teams or QA leads, and be responsible for informing the head of QA and Management.
* Embed Quality‑by‑Design (QbD) and Critical‑to‑Quality (CtQ) principles into study planning and execution to prevent errors that matter.
* Investigate, manage, and track GCP CAPAs, deviations, and other quality issues.
* Collaborate with cross-functional teams to help ensure and strengthen data integrity, data governance, digital traceability, and participant protection.
* Assist with serious breach assessments and notifications per regional requirements.
* Provide guidance and support to Trial Master File activities.
* Review study-specific documents.
* Partner with cross-functional groups and promote compliance.
* Attend governance meetings.
* Identify and address quality systems gaps, including internal process improvements.
* Author, review, or revise SOPs, Work Instructions, Policies, and/or Job Aids.
* Deliver training to internal and external stakeholders.
* Support regulatory inspections and inspection readiness activities.
* Drive an inspection-readiness mindset (e.g., mock interviews, inspections, storyboards, document triage, front-room/back-room orchestration).
* Prepare clinical sites for inspection readiness.
* Review clinical study documents.
* Support other Quality Assurance and Quality Systems activities.
* Develop compliance strategies.
* Provide input and expertise in vendor selection and oversight.
* Prepare and/or assess key quality metrics to support continuous improvement and timely escalation of issues.
* Draft and recommend Quality Agreements for GCP/GLP vendors.
* Direct/supervise personnel; including coaching, mentoring, development, performance management, and administrative tasks.
* Other duties as assigned.
*
* Education and Experience:

*
* Required:

* Bachelor’s degree in a science discipline and at least 10 years’ experience in a QA function within the pharmaceutical/biotech industry (an equivalent combination of experience and education may be considered) with a minimum of 7 years’ supervisory/leadership experience.
* Minimum of 5 years of working in a QA GCP function.
* Previous experience in inspection readiness and audits.
* Previous experience in developing and implementing compliance activities.
* Proven ability to cultivate and develop relationships with cross functional teams, vendors, sites, and other stakeholders.
* Proven ability to interpret applicable FDA, EU and ICH guidelines related to GCP.
* Strong working knowledge of GCP regulations.
* Able to assess issues, perform thorough analysis on complex investigations, and resolve issues in a diplomatic and expeditious manner.

Preferred:
* GVP and GLP knowledge, a plus.
* Auditor certification and/or RQAP-GCP certification, a plus.
* Strong…