Director, Quality Assurance GCP

Crinetics Pharmaceuticals • Napi Headquarters, NM

178d • $176,000 - $220,000

About The Position

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.

Requirements

• Minimum Bachelor’s degree in a science discipline
• At least 12 years’ experience in a QA function within the pharmaceutical/biotech industry
• Minimum of 8 years of working in a GCP QA function
• Previous experience leading inspection readiness and audits
• Thorough understanding of FDA, EU and local regulations, as well as understanding of ICH guidelines
• Hands-on experience in developing and implementing GCP procedures
• Strong working knowledge of GCP and GLP regulations
• Proven ability to cultivate and develop relationships with cross functional teams and vendors
• Demonstrated leadership ability to identify, manage and develop QA teams
• Must be able to make critical and strategic decisions based on risk-assessments
• Capable of managing multiple projects simultaneously
• Excellent communication and listening skills

Nice To Haves

• Auditing certification is a plus

Responsibilities

• Provide GCP quality assurance strategy and oversight of QA GCP operations
• Ensure 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
• 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

Benefits

• Discretionary annual target bonus
• Stock options
• ESPP
• 401k match
• Top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
• 20 days of PTO
• 10 paid holidays
• Winter company shutdown

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 251-500 employees