Role Overview for VP Clinical Quality & Compliance – Philadelphia, PA
JRG Partners is proud to partner with a pioneering, research-driven biopharmaceutical organization based in the vibrant life sciences hub of Philadelphia, PA. Our client is dedicated to developing transformative therapies for patients with severe and life-threatening diseases. They are seeking a visionary and strategic Vice President of Clinical Quality & Compliance to join their executive leadership team. This is a paramount role responsible for providing strategic direction and operational oversight for all clinical quality assurance and compliance activities across the company’s global portfolio.
The VP of Clinical Quality & Compliance will be the ultimate authority on GxP standards, particularly Good Clinical Practice (GCP), and will ensure that all clinical trials and development programs are conducted in strict adherence to global regulatory requirements. This individual will cultivate a robust culture of quality, integrity, and continuous improvement throughout the organization. Reporting directly to the Chief Medical Officer, the VP will be instrumental in safeguarding patient safety, maintaining data integrity, and ensuring the company is perpetually prepared for regulatory inspections. This executive will lead a dedicated team of quality professionals, providing mentorship and guidance to build a world-class clinical quality function. The ideal candidate is a seasoned leader with an extensive track record of success in building and scaling quality systems within a fast-paced, innovative biotech or pharmaceutical environment. This is a unique opportunity to make a significant impact on the development of novel medicines and shape the future of a dynamic and growing company.
Key Responsibilities of VP Clinical Quality & Compliance – Philadelphia, PA
The Vice President of Clinical Quality & Compliance will be accountable for a wide range of critical functions, ensuring the highest standards of quality and regulatory adherence across all clinical development activities. Key responsibilities include:
Strategic Leadership and Vision
Develop, articulate, and execute a comprehensive global clinical quality and compliance strategy that aligns with the company’s long-term goals and evolving regulatory landscape. Provide executive leadership and direction to the Clinical Quality Assurance (CQA) department.
Quality Management System (QMS) Oversight
Direct the design, implementation, and continuous improvement of a robust and scalable Clinical QMS. Ensure the QMS is effective in managing quality events, deviations, CAPAs (Corrective and Preventive Actions), and change control processes related to clinical activities.
Global Regulatory Compliance
Serve as the company’s foremost expert on global clinical regulations. Ensure all clinical trials are conducted in full compliance with applicable regulations and guidelines, including FDA, EMA, and other international health authorities, as well as standards like Good Clinical Practice (GCP), GLP, and GVP.
Audit Program Management
Oversee a comprehensive, risk-based audit program that includes internal process audits, clinical investigator site audits, and vendor/CRO qualification and performance audits. Ensure timely execution of audits and effective resolution of findings.
Inspection Readiness and Management
Lead all activities related to regulatory authority inspections (e.g., FDA, EMA). Develop and implement a robust inspection readiness program, provide training to staff, and act as the primary liaison with inspectors during inspections. Manage all post-inspection communications and commitments.
Team Leadership and Development
Build, lead, and mentor a high-performing team of quality and compliance professionals. Foster a collaborative and proactive culture, promoting professional development and ensuring the team has the necessary skills and resources to succeed.
Cross-Functional Collaboration
Partner closely with leaders in Clinical Operations, Regulatory Affairs, Pharmacovigilance, Data Management, and other R&D functions to embed quality principles into all stages of the clinical development lifecycle. Provide expert quality and compliance guidance to study teams.
Quality Metrics and Reporting
Establish and monitor key quality indicators (KQIs) and key performance indicators (KPIs) to assess the health of the QMS and overall state of compliance. Prepare and present regular reports on quality and compliance status to the executive leadership team and relevant governance bodies.
Documentation and Records Management
Ensure that all clinical trial documentation, including Trial Master Files (TMFs), is maintained in a state of completeness, accuracy, and inspection-readiness in accordance with regulatory requirements.
Continuous Improvement Initiatives
Champion a culture of quality and continuous improvement. Identify opportunities for process enhancements, system upgrades, and efficiency gains within the clinical quality framework to mitigate risk and enhance operational excellence.
Requirements for the VP Clinical Quality & Compliance – Philadelphia, PA
We are seeking a distinguished leader with deep expertise and a proven history of success in the biopharmaceutical industry. The ideal candidate will possess the following qualifications and attributes:
Required Qualifications:
Education
An advanced degree (e.g., MS, PhD, PharmD, MD) in a relevant scientific or healthcare discipline is required.
Experience
A minimum of 15 years of progressive experience in the pharmaceutical, biotechnology, or medical device industry, with at least 10 years in a senior leadership role within Clinical Quality Assurance, GxP Compliance, or a related function.
Regulatory Expertise
Demonstrated expert-level knowledge of global GxP regulations, particularly FDA and EMA regulations, and ICH guidelines governing clinical trials.
Leadership Experience
Proven track record of successfully building, leading, and developing high-performing global quality teams. Experience managing departmental budgets and resources effectively.
Inspection Management
Extensive, hands-on experience in leading and managing regulatory authority inspections from major health agencies.
Global Trial Experience
Significant experience providing quality oversight for global clinical trials across all phases (Phase I-IV) in multiple therapeutic areas.
Strategic Acumen
Strong strategic thinking skills with the ability to translate corporate objectives into actionable quality and compliance strategies.
Preferred Qualifications:
- Experience in a rapidly growing, pre-commercial or newly commercial biopharmaceutical company.
- Experience with a variety of therapeutic modalities, such as biologics, cell/gene therapy, or small molecules.
- Formal certification in quality management (e.g., ASQ CQA, RQAP-GCP) is a plus.
- Demonstrated ability to influence and negotiate effectively with all levels of the organization, from study teams to the executive suite.
- Exceptional communication (written and verbal), interpersonal, and presentation skills.
- A proactive, solutions-oriented mindset with strong analytical and problem-solving capabilities.
- Unquestionable personal integrity and a strong commitment to ethical conduct.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a highly competitive and comprehensive compensation and benefits package. This includes:
Executive Compensation
A competitive base salary complemented by a significant annual performance-based bonus.
Equity Ownership
A substantial long-term incentive package, including stock options or restricted stock units (RSUs), allowing you to share in the company’s success.
Comprehensive Health Coverage
Premium medical, dental, and vision insurance plans for you and your eligible dependents with low employee contributions.
Retirement Savings
A 401(k) retirement plan with a generous company match to help you plan for your future.
Work-Life Balance
A generous paid time off (PTO) policy, including vacation, sick leave, and company-paid holidays.
Professional Growth
A strong commitment to employee development with funding for conferences, training, and continued education.
Relocation Support
A comprehensive relocation assistance package for qualified candidates moving to the Philadelphia area.
Wellness Programs
Company-sponsored wellness initiatives, including gym memberships, mental health resources, and employee assistance programs.
How to Apply
This is an exclusive search being conducted by JRG Partners. To be considered for this exceptional leadership opportunity, please submit your resume and a cover letter outlining your qualifications and interest in the role. We encourage all qualified individuals to apply promptly. If you have any questions or wish to discuss the position in more detail, please contact our dedicated recruitment team.
JRG Partners specializes in connecting elite talent with leading organizations in the life sciences sector. To learn more about our expertise and other opportunities, please visit our Clinical Research Recruiters practice area page. We look forward to reviewing your application.
