Director, Quality Assurance GCP

Director, Quality Assurance (GCP)

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.

The Director, Quality Assurance (GCP) oversees the development, implementation, maintenance, and performance of GCP Quality Assurance systems both within company and external vendors. The Director will execute and / or ensure proper oversight of the GCP QA audit program management, clinical operations phase 1 to phase 4 study team support, regulatory inspections, and GCP QA infrastructure development.

These may include but are not limited to :

• Provide GCP quality assurance strategy and oversight of QA GCP operations
• Ensures that clinical trials and research activities adhere to regulatory requirements, industry standards, and internal policies
• Develop and implement risk management strategies to identify, assess, and mitigate risks
• Drive effective initiatives that foster a culture of quality and continuous improvement
• Successfully collaborate on multiple projects with cross-functional stakeholders
• Lead investigations of significant complexity
• Prepare and present to executive management
• Manage, lead, and mentor quality assurance team members; lead cross-functional teams on compliance projects

• Develop a plan with CROs for clinical sites' audit execution
• Manage clinical site, TMF, and GCP and GLP vendor audit activities
• Generate and / or review and approve overall GCP QA audit plans and schedules
• Generate and / or review and approve audit trend reports
• Execute the GCP QA audit program to ensure that processes and systems are adequate for communicating, addressing, and preventing identified GCP compliance issues and trends

• Represent QA at program-wide (e.g., study team or governance) 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 responsible for informing the head of QA and Management, as required
• Manage quality events, CAPAs, and deviations
• Collaborate with cross-functional teams (Clinical Operations, Clinical Research, Regulatory, etc.) to embed quality by design in clinical programs.
• Provide guidance and support to Trial Master File activities

• Ensure adequate systems and controls are in place for GCP compliance
• Identify and address quality systems gaps, including internal processes and personnel GCP training
• Execute the review of GCP SOP tracking and status reports to ensure timely review and development of SOPs
• Author, review, or revise SOPs related to clinical and non-clinical studies
• Develop and provide GCP training
• Support regulatory inspection activities
• and GCP inspection readiness activities
• Prepare internal team, clinical sites, and vendors for inspection readiness
• Thoroughly review clinical study documents
• Perform breach assessments
• Oversee quality vendor management and governance for GCP and GLP vendors
• Review Quality Agreements to ensure clear delineation of responsibilities and compliance expectations between the sponsor and the vendor
• Contribute and present GCP quality events and metrics at the Quality Management Review meeting
• Support other Quality Assurance and Quality Systems activities
• Other duties as assigned.

Required :

• Minimum…