Senior/Executive Director, Clinical Quality Assurance at Green Key Resources Senior/Executive Director, Clinical Quality Assurance at Green Key Resources in NORTH WALTHAM, Massachusetts Posted in 10 days ago.

Type:

full-time

Job Description:

A global, innovation?driven biopharmaceutical sponsor is seeking an accomplished Senior Director/Executive Director of Clinical Quality Assurance to provide strategic leadership and operational oversight across its

GLP/GCP/GVP

quality programs. This senior leader will shape and elevate the company's clinical quality vision, ensure inspection readiness, and drive compliance excellence across a diverse portfolio of development programs. This is a high?visibility role within the enterprise Quality leadership team, responsible for strengthening Quality culture, advancing the QMS, and ensuring global GXP compliance across all clinical activities. The ideal candidate is a seasoned Clinical QA leader with deep regulatory expertise, proven success building high?performing teams, and the ability to influence effectively in a matrixed environment. Key Responsibilities Develop and execute the Clinical QA strategic roadmap aligned to program and business objectives. Lead cross?functional risk management initiatives with Clinical Development and Safety to ensure patient protection and robust quality oversight. Establish functional goals, budgets, headcount plans, and performance metrics. Provide forward?looking regulatory and industry insight to anticipate evolving

GCP/GVP/GLP

expectations. Serve as the senior Clinical QA representative on program teams and study teams. Ensure global

GCP/GVP/GLP

compliance across all clinical trial activities. Apply Quality by Design and Critical?to?

Quality principles (ICH E8(R1), ICH E6(R2/R3)) to guide risk assessments, audit strategy, and inspection readiness. Oversee development, harmonization, and continuous improvement of clinical quality systems, SOPs, policies, and governance frameworks. Maintain appropriate interfaces with GMP?related quality functions Lead a comprehensive, risk?based

GCP/GVP/GLP

audit program (internal, CRO/vendor, clinical site). Evaluate audit findings for impact on subject safety, data integrity, and compliance; ensure timely and effective CAPA closure. Drive inspection readiness initiatives including mock BIMO interviews, preparedness plans, and cross?functional training. Host sponsor inspections and support CRO inspection activities. Partner closely with Clinical Operations, Medical Affairs, Pharmacovigilance, Regulatory, Biostatistics, Data Management, and external partners to ensure operational compliance. Review and contribute to INDs, protocols, IBs, NDAs, and other submission?related documents. Implement and maintain a risk?based oversight strategy covering trial conduct, site compliance, data integrity, and safety reporting. Support investigations of deviations, noncompliance, and GCP violations with strong root?cause analysis and CAPA management. Escalate compliance risks and recommend mitigation strategies to senior leadership. Lead GCP training programs and communicate regulatory updates and best practices across the organization. Build, mentor, and develop Clinical QA staff across sites. Promote a culture of accountability, collaboration, and continuous improvement. Manage internal and external QA resources, including contract auditors. Key Qualifications Basic Requirements Bachelor's degree in life sciences, pharmacy, nursing, or related discipline. Preferred Qualifications 12+ years of experience in sponsor?side clinical QA within high?throughput clinical development environments. 6+ years of direct GCP leadership experience. Deep understanding of GLP, GCP, and GVP regulations across global jurisdictions. Extensive experience hosting regulatory inspections (FDA, EMA, MHRA, Health Canada, Asia). Proven success managing teams across multiple sites and geographies. Strong communication, collaboration, influencing, and problem?solving skills. Ability to lead effectively in a matrixed environment.