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.

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 :

• 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

Study Team Support & Issue Escalation Management

Quality Systems / Inspections / Infrastructure

Education and Experience

Required :

Preferred :

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.