Director Clinical Quality Assurance
The Director of Clinical Quality Assurance (QA) will be responsible for building & leading the GCP QA team which provides QA support to clinical study teams. This leader will be skilled at leading teams through pre-approval inspections, building GCP processes, and has in-depth knowledge of current GCP practices. This individual will be the subject matter expert in Good Clinical Practice (GCP), develop standards and partner with Clinical Operations, Regulatory, Biostatistics, Safety, Medical Research, and other functions to establish and document risk-based GCP processes and procedures. The Director, Clinical QA will ensure compliance with applicable regulations with regards to sponsor oversight of clinical programs.
- Build the GCP QA capability designed to serve as counsel and QA support for the clinical portfolio while maintaining a strong independent role for QA decision-making.
- Assist in developing, implementing, and communicating the GCP QA vision, goals, core capabilities, and value while championing a strong Quality Culture.
- Establish strong, effective working relationships with internal and external stakeholders to achieve GCP compliance and Quality objectives.
- Proactively assess compliance issues and risks, providing strong leadership and expertise in maintaining GCP compliance standards.
- Serve as the expert GCP consultant for issue management & issue escalation, with a focus on critical and major quality events.
- Communicate critical risks to senior leadership, requiring diplomatic and objective representation of the issue(s).
- Aide in the development, implementation, and enhancements to the clinical QMS.
- Participate in preparations for regulatory inspections, which may include reviewing Inspection Readiness Planning, Mock Inspections, and risk-based management of program inspection quality events.
- Support investigational new drug applications, ex-US clinical trial applications (CTA), and related correspondence from global regulatory authorities.
- Invest deeply in team development plans; serve as a coach and mentor to others.
Requirements & Experience
- GCP QA professional with broad drug/device experience which spans all clinical phases (Phase I to Phase IV).
- Broad understanding of international regulations and guidance documents, with a focus on FDA & EMA regulations.
- A proven track record of demonstrating good judgement & decision-making experience.
- Ability to concisely present quality events and the criticality to internal senior leaders.
- Excellent interpersonal, verbal, and written communication skills with the ability to diplomatically address quality issues.
- Well-prepared, competent, and confident when interacting with senior leadership, regulatory authorities, and internal and external partners
- Analyze complex situations / issues and effectively communicate situations / issues, along with potential recommendations, to various functional groups.
- Experience with developing & implementing GCP QA systems, processes, and procedures.
- Ability to remain objective/autonomous in implementing the Quality Program, while at the same time taking ownership and proactively working with the rest of the team to achieve the desired quality objectives
- Conducted GCP audits and actively participated in regulatory inspections.
- Strong experience in IND and CTA filings; NDA/BLA/MAA experience strongly preferred
- A mentor, trusted advisor, and advocate for Quality with the ability to influence change and invest deeply in the company mission.
- Bachelor’s degree in a scientific discipline is required. An advanced degree is preferred
- 12+ years of relevant experience in a biotech/pharmaceutical setting including a GCP leadership role