divh2Director, Quality Assurance (GCP)/h2pCrinetics 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 worlds premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others./ph3Position Summary/h3pThe 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./ph3Essential Functions and Responsibilities/h3pThese may include but are not limited to:/pulliProvide GCP quality assurance strategy and oversight of QA GCP operations/liliEnsures that clinical trials and research activities adhere to regulatory requirements, industry standards, and internal policies/liliDevelop and implement risk management strategies to identify, assess, and mitigate risks/liliDrive effective initiatives that foster a culture of quality and continuous improvement/liliSuccessfully collaborate on multiple projects with cross-functional stakeholders/liliLead investigations of significant complexity/liliPrepare and present to executive management/liliManage, lead, and mentor quality assurance team members; lead cross-functional teams on compliance projects/li/ulh3Audit Management/h3ulliDevelop a plan with CROs for clinical sites audit execution/liliManage clinical site, TMF, and GCP and GLP vendor audit activities/liliGenerate and/or review and approve overall GCP QA audit plans and schedules/liliGenerate and/or review and approve audit trend reports/liliExecute the GCP QA audit program to ensure that processes and systems are adequate for communicating, addressing, and preventing identified GCP compliance issues and trends/li/ulh3Study Team Support Issue Escalation Management/h3ulliRepresent QA at program-wide (e.g., study team or governance) meetings and provide GCP guidance and feedback/liliServe 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/liliManage quality events, CAPAs, and deviations/liliCollaborate with cross-functional teams (Clinical Operations, Clinical Research, Regulatory, etc.) to embed quality by design in clinical programs./liliProvide guidance and support to Trial Master File activities/li/ulh3Quality Systems / Inspections / Infrastructure/h3ulliEnsure adequate systems and controls are in place for GCP compliance/liliIdentify and address quality systems gaps, including internal processes and personnel GCP training/liliExecute the review of GCP SOP tracking and status reports to ensure timely review and development of SOPs/liliAuthor, review, or revise SOPs related to clinical and non-clinical studies/liliDevelop and provide GCP training/liliSupport regulatory inspection activities/liliand GCP inspection readiness activities/liliPrepare internal team, clinical sites, and vendors for inspection readiness/liliThoroughly review clinical study documents/liliPerform breach assessments/liliOversee quality vendor management and governance for GCP and GLP vendors/liliReview Quality Agreements to ensure clear delineation of responsibilities and compliance expectations between the sponsor and the vendor/liliContribute and present GCP quality events and metrics at the Quality Management Review meeting/liliSupport other Quality Assurance and Quality Systems activities/li/ululliOther duties as assigned./li/ulh3Education and Experience/h3pRequired:/pulliMinimum Bachelors 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)/liliMinimum of 8 years of working in a GCP QA function/liliPrevious experience leading inspection readiness and audits/liliThorough understanding of FDA, EU and local regulations, as well as understanding of ICH guidelines/liliHands-on experience in developing and implementing GCP procedures/liliStrong working knowledge of GCP and GLP regulations/liliProven ability to cultivate and develop relationships with cross functional teams and vendors/liliDemonstrated leadership ability to identify, manage and develop QA teams/liliMust be able to make critical and strategic decisions based on risk-assessments/liliCapable of managing multiple projects simultaneously/liliExcellent communication and listening skills/li/ulpPreferred:/pulliAuditing certification is a plus/li/ulh3Physical Demands and Work Environment/h3pPhysical 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./ppLaboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply./ph3Travel/h3pYou may be required to travel for up to 10% of your time./ph3The Anticipated Base Salary Range/h3p$176,000 $220,000/ppIn 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./ppThe 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./ph3Equal Opportunity Employer/h3pCrinetics 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./ph3Vaccination Requirement/h3pFollowing 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./p/div