Crinetics Pharmaceuticals

Associate Director, Quality Assurance GCP

Remote, USA · Director

Sponsorship not specified$150k-$186kDetected 91 days ago

GCPPerformance ManagementFDA RegulatoryAnimal StudiesLeadershipCollaborationMentoringGxP

About the role

Essential Job Functions and Responsibilities:
These may include but are not limited to:
Generate and/or review GCP and GLP QA audit plans and schedules, tailoring scope and depth to study/process risk and complexity.

Manage or perform clinical site, internal, TMF, GCP, and GLP vendor audits.
Generate and/or review and approve audit trend reports across programs to identify systemic issues and drive preventive actions.
Develop and manage audit programs.
Serve as point of escalation for GCP compliance issues identified by clinical study teams or QA leads, and be responsible for informing the head of QA and Management.
Embed Quality ‑ by ‑ Design (QbD) and Critical ‑ to ‑ Quality (CtQ) principles into study planning and execution to prevent errors that matter.
Investigate, manage, and track GCP CAPAs, deviations, and other quality issues.
Collaborate with cross-functional teams to help ensure and strengthen data integrity, data governance, digital traceability, and participant protection.
Provide guidance and support to Trial Master File activities.
Review study-specific documents.

Minimum of 5 years of working in a QA GCP function.
Previous experience in inspection readiness and audits.
Proven ability to interpret applicable FDA, EU and ICH guidelines related to GCP.
Strong working knowledge of GCP regulations.
Some walking and lifting up to 25 lbs. may be required.
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.
You may be required to travel for up to 40% of your time.

The salary range for this position is: $150000 - $186000.
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match.
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.
The Anticipated Base 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.

Crinetics is a pharmaceutical company based in San Diego, California that develops much-needed therapies for people with rare endocrine diseases.
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 robust pipeline across preclinical and clinical development.
We are driven by science with a patient-centric and team-oriented culture.
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.
Come join our team as we transform the lives of others.

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.
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.

tation, 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 s

This listing is sourced directly from Crinetics Pharmaceuticals's careers page and normalized into a canonical job model.