[Hiring] Director, Quality Assurance GCP @Crinetics Pharmaceuticals, Inc.

Role Description

The Director, Quality Assurance (GCP) oversees the development, implementation, maintenance, and performance of GCP Quality Assurance systems both within the company and external vendors.

• Provide GCP quality assurance strategy and oversight of QA GCP operations
• Ensure that clinical trials and research activities adhere to regulatory requirements, industry standards, and internal policies
• Develop and implement risk management strategies to identify, assess, and mitigate risks
• Drive effective initiatives that foster a culture of quality and continuous improvement
• Successfully collaborate on multiple projects with cross-functional stakeholders
• Lead investigations of significant complexity
• Prepare and present to executive management
• Manage, lead, and mentor quality assurance team members; lead cross-functional teams on compliance projects

Qualifications

• 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, as well as 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

Requirements

• Auditing certification is a plus

Benefits

• Discretionary annual target bonus
• Stock options
• ESPP
• 401k match
• Top-notch health insurance plans for employees (and their families) including medical, dental, vision, and basic life insurance
• 20 days of PTO
• 10 paid holidays
• Winter company shutdown