Director, Quality Assurance – GCP
Employment Information
Job Description
Director, Quality Assurance managing GCP Quality Assurance systems at Crinetics Pharmaceuticals. Overseeing audit programs and ensuring compliance with regulatory requirements in clinical trials.
Responsibilities:
- Oversee the development, implementation, maintenance, and performance of GCP Quality Assurance systems
- Ensure clinical trials and research activities adhere to regulatory requirements and internal policies
- Develop and implement risk management strategies to identify, assess, and mitigate risks
- Drive initiatives that foster a culture of quality and continuous improvement
- Lead investigations of significant complexity and present to executive management
- Manage and mentor quality assurance team members
- Represent QA at program-wide meetings and provide GCP guidance
- Manage quality events, CAPAs, and deviations
- Ensure adequate systems and controls are in place for GCP compliance
- Execute GCP QA audit program to ensure that processes and systems are adequate for communicating, addressing, and preventing identified GCP compliance issues and trends
Requirements:
- Minimum Bachelor’s degree in a science discipline
- At least 12 years’ experience in a QA function within the pharmaceutical/biotech industry
- Minimum of 8 years of working in a GCP QA function
- Previous experience leading inspection readiness and audits
- Thorough understanding of FDA, EU and local regulations
- Understanding of ICH guidelines
- Hands-on experience in developing and implementing GCP procedures
- Strong working knowledge of GCP and GLP regulations
- Proven ability to cultivate and develop relationships with cross-functional teams and vendors
- Demonstrated leadership ability to identify, manage and develop QA teams
- Must be able to make critical and strategic decisions based on risk-assessments
- Capable of managing multiple projects simultaneously
- Excellent communication and listening skills.
- Auditing certification is a plus
Benefits:
- Discretionary annual target bonus
- Stock options
- Employee Stock Purchase Plan (ESPP)
- 401k match
- 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
- Winter company shutdown
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