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
• Support other Quality Assurance and Quality Systems activities

• Other duties as assigned.

Education and Experience

Required:

• Minimum Bachelor’s degree in a science discipline and at least 12 years’ experience in a QA function within the pharmaceutical/biotech industry (an equivalent combination of experience and education may be considered)
• 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

Preferred:

• Auditing certification is a plus

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 those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.

Travel:

You may be required to travel for up to 10% of your time.

The Anticipated Base Salary Range: $176,000 – $220,000

In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide 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, and a winter company shutdown.

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.

Equal Opportunity Employer:

Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.

Vaccination requirement:

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

Salary Range

In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide 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, and a winter company shutdown.