Crinetics Pharmaceuticals

Senior Manager, Quality Assurance GCP

San Diego, CA, USA · Senior

Sponsorship not specified$133k-$166kDetected 62 days ago

GCPComplianceVendor ManagementFDA RegulatoryResearchAnimal StudiesCommunicationCollaborationProblem SolvingGxP

About the role

Maintain trackers and trend audit findings / CAPAs / resolution processes across programs to identify systemic issues and drive preventive actions.
Manage and perform vendor risk assessments.
Maintain and archive QA electronic vendor files and audit documentation.
Manage GCP and GLP quality agreements with vendors.
Provide guidance and support to Trial Master File activities.
Review clinical study documents (protocols, ICFs, study plans, IB, CSR, etc.) of moderate complexity and provide feedback.
Foster a collaborative environment that supports GCP compliance and continuous improvement; identify and mitigate potential compliance risks.

Manage, oversee, conduct, and report on assigned GCP and GLP qualification and routine vendor audits and others as required (internal system/process, TMF, clinical site, data, and clinical documents).

The salary range for this position is: $133,000 - $166,000.
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match.
Generate and maintain annual audit programs and manage schedules.

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, 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.

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.