Instil Bio is seeking a Director / Senior Director of R&D Quality and Compliance who will serve as a strategic and tactical quality professional in managing compliance related to Good Clinical Practices (GCP’s), Good Laboratory Practices (GLP’s), Good Pharmacovigilance Practices (GPVP’s) and other related activities. Responsible for ensuring oversight of compliance with GCP, GLP, and GPVP global regulations, industry best practices, and internal policies and procedures. Partner with the Clinical Development, Clinical Operations, and Pharmacovigilance organizations to provide strategic GCP, GLP, and GPVP compliance oversight for clinical studies and internal operations.
Responsibilities
These may include but are not limited to:
- Attend project meetings, representing Quality and Compliance and provide GCP/GPVP/GLP insight and oversight
- Perform review and gap analysis of existing quality systems and lead development and implementation of additional or alternative solutions
- Design and implement a risk- based audit program
- Plan, manage, and perform GCP/PVP/GLP audits: Investigational sites, various vendors supporting conduct of clinical studies, GCP/GVP/GLP system audits, clinical studies report, etc.
- Evaluate audit observations and trends and develop periodic compliance reports for management
- Monitor and drive quality issues to resolution. (e.g., Closure of Audit Reports, develop and track post auditing corrective actions plans, as applicable)
- Responsible for managing GCP/GPVP/GLP compliance activities / non-conformances associated with drug development programs
- Understand and interpret current pharmaceutical regulations and ICH guideline requirements pertaining to GCP/GPVP/GLP and advise the Clinical development teams on all relevant issues
- Review Clinical Development SOPs to ensure compliance with all applicable regulatory authorities
- Work in conjunction with other Quality areas to ensure proper representation throughout the organization, as needed
- Conduct internal system audits to ensure compliance with applicable regulations, SOPs and policies and advice on process improvements in the functional areas
- Ensure annual audit plans are developed and audit activities are completed according to plan
- Communicating audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to ensure appropriate implementation of Corrective and Preventive Action Plans (CAPAs), addressing root causes
- Lead management of regulatory agency inspections and coordination of responses to any regulatory agency finding
- May lead change projects which have strategic impact on the organization
- Analyze trends in industry/regulatory environment that would necessitate future changes
- Facilitate and support inspection readiness activities
- Develop and provide independent periodic reports to management on overall compliance status
- Ensure that the company, its contractors, and vendors are prepared for FDA and Health Authority inspections
Requirements, Knowledge, Skills and Abilities
- Minimum of bachelor’s degree in a scientific discipline with at least 12 years of work experience in the Pharmaceutical/Biotechnology industry with at least 5 years in Quality (an equivalent combination of education and experience may be considered)
- Expert knowledge of FDA and ICH GxP regulations and guidelines with focus on GCP, GLP, and GPVP
- Experience in leading high performing Quality teams
- Experience in hosting and managing GCP FDA and Health Authority inspections
- Excellent people leader with strong coaching and mentoring skills
- Experience identifying and evaluating risks and executing efficient and effective mitigations
- Practical knowledge and experience identifying key performance metrics for quality indicators, setting targets to maintain a state of control while identifying areas for improvement.
- Track record of strong personal performance combined with demonstrated ability to build and lead high performing teams in a fast growth environment
- Demonstrated problem-solving and critical thinking skills
- Demonstrated ability to work effectively in a dynamic, complex, and fast-paced team environment
- Travel may be required up to 20% of the time