Role Overview for EVP, Global Quality Assurance with a Biopharma Company – Princeton, NJ
JRG Partners is proud to partner with a pioneering, research-driven biopharmaceutical company in the search for an exceptional Executive Vice President (EVP) of Global Quality Assurance. Based in the dynamic life sciences hub of Princeton, NJ, this is a career-defining opportunity to join the executive leadership team and shape the future of quality and compliance for a company dedicated to developing life-changing therapies for patients with unmet medical needs. The successful candidate will be a visionary leader with a profound understanding of the global regulatory landscape and a passion for embedding a culture of quality excellence across the entire organization.
As the EVP of Global Quality Assurance, you will hold the ultimate responsibility for the strategic direction, development, and execution of the global Quality Management System (QMS). Your leadership will ensure that all aspects of the company’s operations, from early-stage research and clinical development through to commercial manufacturing and post-market surveillance, adhere to the highest standards of quality and are in full compliance with global GxP regulations (GMP, GCP, GLP, GVP).
This role is not merely about compliance; it is about championing a proactive, risk-based quality mindset that drives continuous improvement, enhances operational efficiency, and ultimately safeguards patient safety while enabling business success. You will be the organization’s senior-most quality advocate, interacting with the Board of Directors, executive leadership, regulatory authorities, and key external partners. Your strategic influence will be critical in navigating the complexities of a global supply chain, new product introductions, and an evolving regulatory environment, ensuring the company maintains its reputation for integrity and excellence.
Key Responsibilities of EVP, Global Quality Assurance with a Biopharma Company – Princeton, NJ
The EVP, Global Quality Assurance will have a broad and impactful remit. Key responsibilities are comprehensive and include, but are not limited to, the following areas:
Strategic Leadership and Vision
- Develop and implement a forward-thinking global quality strategy and vision that aligns with the company’s long-term corporate objectives and patient-centric mission.
- Serve as a key member of the executive leadership team, providing expert counsel on all quality and compliance-related matters to inform strategic business decisions.
- Establish and champion a robust “Culture of Quality” throughout the organization, ensuring that quality principles are understood, embraced, and practiced by all employees at every level.
- Chair the Quality Management Review board, presenting comprehensive analyses of QMS performance, compliance risks, and strategic initiatives to executive leadership.
Global Quality Systems and Operations
- Provide executive oversight for the design, implementation, and continuous improvement of a phase-appropriate, global Quality Management System (QMS) across all GxP disciplines.
- Ensure all quality systems (e.g., CAPA, Deviations, Change Control, Document Management, Training) are efficient, effective, and compliant with current global regulations.
- Oversee the global supplier quality management program, including the qualification, auditing, and performance monitoring of all contract manufacturing organizations (CMOs), contract research organizations (CROs), and critical material suppliers.
- Direct all product quality activities, including batch record review, product disposition, stability programs, and the management of product complaints and recalls.
Regulatory Compliance and Inspection Management
- Act as the primary point of contact and company representative for all interactions with global regulatory health authorities (e.g., FDA, EMA, PMDA) on quality and compliance matters.
- Lead the strategy and execution for all regulatory inspections, ensuring a state of constant inspection readiness across all global sites and functions.
- Maintain expert-level knowledge of evolving global GxP regulations, guidelines, and industry best practices, ensuring the company’s quality systems adapt proactively to changes.
- Oversee the preparation and review of quality-related sections of regulatory submissions (e.g., IND, BLA, MAA).
Team Leadership and Development
- Lead, mentor, and develop a high-performing global quality assurance organization, fostering a collaborative and innovative environment.
- Structure the global QA team for scalability and success, ensuring the right talent and resources are in place to support a growing and diverse product pipeline.
- Establish clear performance goals and development plans for direct reports and the wider quality team, promoting career growth and succession planning.
- Manage the global quality budget, ensuring optimal allocation of resources to meet strategic objectives and compliance requirements.
Requirements for the EVP, Global Quality Assurance with a Biopharma Company – Princeton, NJ
The ideal candidate will be a seasoned and respected leader in the biopharmaceutical industry with a proven track record of building and leading world-class quality organizations.
Educational & Professional Qualifications
- An advanced degree (Ph.D., M.D., Pharm.D. or Master’s) in a relevant scientific or life sciences discipline is required.
- A minimum of 20 years of progressive experience in Quality Assurance within the biopharmaceutical or pharmaceutical industry.
- At least 10 years of experience in a senior leadership role (e.g., Vice President or equivalent) with responsibility for global quality operations.
- Extensive experience with a range of biologic product modalities (e.g., monoclonal antibodies, cell and gene therapies, vaccines) is highly desirable.
Technical Expertise and Experience
- Demonstrated mastery of global GxP regulations and guidelines, including deep expertise in current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
- Proven experience successfully hosting and managing regulatory inspections from major global health authorities, including the FDA and EMA.
- Direct experience in quality oversight for both clinical-stage and commercial products is essential.
- Strong experience managing quality for outsourced manufacturing and development activities through a robust supplier quality management program.
Leadership Competencies
- Exceptional strategic thinking and problem-solving skills, with the ability to translate complex quality and regulatory concepts into actionable business strategies.
- Outstanding communication and interpersonal skills, with the ability to influence and build consensus with diverse stakeholders, from the manufacturing floor to the Board of Directors.
- Proven ability to lead through change, inspire teams, and build a positive and accountable culture.
- Unquestionable integrity, ethics, and a deep commitment to patient safety and product quality.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier executive talent and offers a highly competitive and comprehensive compensation and benefits package, including:
Executive Compensation
A highly competitive base salary, annual performance-based bonus, and a significant long-term incentive package (stock options/RSUs).
Comprehensive Health & Wellness
Premium medical, dental, and vision insurance for you and your dependents, along with a robust employee wellness program, and generous life and disability insurance.
Retirement Savings
A 401(k) 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 holidays, to support a healthy work-life integration.
Relocation Assistance
A comprehensive relocation package is available for the successful candidate and their family.
Professional Development
A significant budget for continuous learning, executive coaching, and participation in industry conferences to ensure you remain at the forefront of the field.
How to Apply
JRG Partners has been exclusively retained for this critical executive search. To express your interest in this exceptional opportunity, please submit your confidential CV and a cover letter detailing your qualifications and leadership philosophy. We are committed to a transparent and respectful recruitment process. Qualified candidates will be contacted directly by one of our senior consultants for an initial discussion.
To apply or to learn more about our expertise in this area, please visit the JRG Partners’ Life Sciences executive search practice page. We look forward to hearing from you and exploring how your experience can help shape the future of our client’s success.
