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. 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 Senior Manager, Quality Assurance GCP will support the Good Clinical Practice (GCP) Quality Assurance (QA) function, and performance of GCP QA operations. The role also supports QA oversight for non-clinical laboratory, including Good Laboratory Practice (GLP). This individual will manage and oversee assigned audits, support regulatory inspections, and support the quality oversight and compliance program at Crinetics Pharmaceuticals.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
- Manage audits and audit finding resolution process.
- Manage, oversee, conduct, and report assigned GCP routine audits (internal system/process, TMF, clinical investigator site, vendors, data, and clinical documents).
- Manage and perform vendor risk assessments. Generate and maintain annual audit plans; maintain trackers and trend audit findings.
- Maintain and archive QA electronic vendor files and audit documentation.
- Reconcile master vendor tracker and vendor records.
- Manage GCP quality agreements.
- Attend vendor governance and oversight meetings.
- Provide GCP guidance and feedback for research and development activities; participate in clinical study team meetings and discuss clinical study related compliance topics. Identify and escalate significant compliance risks to senior management.
- Review clinical study documents (protocols, study plans, IB, CSR, etc.) of moderate complexity to provide feedback.
- Foster a collaborative environment that supports GCP compliance and continuous improvement; identify and mitigate potential compliance risks.
- Review deviations, quality issues, and CAPAs; perform investigations and root cause analysis.
- Develop and maintain professional cross-functional and cross-departmental relationships.
- Interpret and apply global regulations of moderate complexity.
- Identify compliance gaps and develop corrections or improvements.
- Support inspection-readiness activities and regulatory inspections.
- Develop, modify, and execute SOPs or Work Instructions.
- Timely completion of required training.
- Manage multiple projects simultaneously.
- Develop training materials with minimal support; administer GCP training.
- Support other quality driven activities and initiatives.
Education and Experience:
Required:
- Minimum with a Bachelor’s degree and at least 8 years of experience in a QA function within the pharmaceutical/biotech industry (an equivalent combination of experience and education may be considered).
- 5 years of experience in a supervisory role.
- Ability to interpret FDA, EU, ICH, and other global GCP regulations.
- Previous experience leading GCP QA audits (vendor, investigator site, internal).
- Provide guidance to auditors and junior level staff; manage and supervise auditor activities and assign tasks and goals.
- Knowledge working with QMS in vendor management, SOPs, internal audits, deviations, and CAPAs.
- Demonstrates sound analytical and problem-solving abilities to resolve complex issues that involve numerous components.
- Excellent collaboration, interpersonal, verbal, and written communication skills.
- Outstanding organizational, prioritization skills, with attention to detail.
- Good presentation skills to both internal and external audiences.
- Able to work on issues where analysis of situations or data require conceptional thinking and in-depth knowledge.
- Able to facilitate moderate to complex investigations.
- Has knowledge and experience using a risk-based approach.
Preferred:
- Experience in GLP and GVP a plus.
- Regulatory inspection experience highly desired.
- Auditor certification/credential 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.
Travel:
You may be required to travel for up to 35% of your time.
The Anticipated Base Salary Range: $117,000-$156,000
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.
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