Director, Quality Assurance GCP

Role Summary

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

Responsibilities

• 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
• 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
• Develop a plan with CROs for clinical sites‚Äô audit execution
• Manage clinical site, TMF, and GCP and GLP vendor audit activities
• Generate and/or review and approve overall GCP QA audit plans and schedules
• Generate and/or review and approve audit trend reports
• Execute the GCP QA audit program to ensure that processes and systems are adequate for communicating, addressing, and preventing identified GCP compliance issues and trends
• Represent QA at program-wide meetings and provide GCP guidance and feedback
• Serve as point of escalation for GCP compliance issues identified by clinical study teams or QA leads
• Manage quality events, CAPAs, and deviations
• Collaborate with cross-functional teams to embed quality by design in clinical programs
• Provide guidance and support to Trial Master File activities
• Ensure adequate systems and controls are in place for GCP compliance
• Identify and address quality systems gaps, including internal processes and personnel GCP training
• Review GCP SOP tracking and status reports to ensure timely review and development of SOPs
• Author, review, or revise SOPs related to clinical and non-clinical studies
• Develop and provide GCP training
• Support regulatory inspection activities and GCP inspection readiness activities
• Prepare internal team, clinical sites, and vendors for inspection readiness
• Thoroughly review clinical study documents
• Perform breach assessments
• Oversee quality vendor management and governance for GCP and GLP vendors
• Review Quality Agreements to ensure clear delineation of responsibilities and compliance expectations between the sponsor and the vendor
• Present GCP quality events and metrics at the Quality Management Review meeting
• Support other Quality Assurance and Quality Systems activities
• Other duties as assigned

Qualifications

• Minimum Bachelor‚Äôs degree in a science discipline and at least 12 years‚Äô experience in a QA function within the pharmaceutical/biotech industry (equivalent combination acceptable)
• Minimum of 8 years of experience in a GCP QA function
• Previous experience leading inspection readiness and audits
• Thorough understanding of FDA, EU and local regulations, and ICH guidelines
• Hands-on experience in developing and implementing GCP procedures
• Strong working knowledge of GCP and GLP regulations
• Ability to cultivate and develop relationships with cross-functional teams and vendors
• Demonstrated leadership ability to identify, manage and develop QA teams
• Ability to make critical and strategic decisions based on risk assessments
• Capable of managing multiple projects simultaneously
• Excellent communication and listening skills

Preferred

• Auditing certification is a plus

Additional Requirements

• Physical Activities: Sit at desk for long periods; occasional walking and lifting up to 25 lbs; teamwork in a low to moderate noise environment
• Travel: Up to 20% of time