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.

POSITION SUMMARY:

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.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

These may include but are not limited to:

General

• 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
   

Audit Management

• 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

Study Team Support & Issue Escalation Management

• 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

Quality Systems / Inspections / Infrastructure

• 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