Role Overview for VP, Quality Assurance with a Biologics Manufacturer – Boston, MA
JRG Partners is exclusively representing a pioneering, fast-growing biologics manufacturer at the forefront of developing next-generation therapeutics. Located in the vibrant biotechnology hub of Boston, MA, our client is dedicated to addressing unmet medical needs through innovative science and a commitment to excellence. We are seeking a visionary and strategic executive to join their senior leadership team as the Vice President of Quality Assurance.
This is a paramount role responsible for providing the strategic direction, leadership, and operational oversight for all quality and compliance functions across the organization. The VP, Quality Assurance will be the ultimate authority on product quality, ensuring that all GxP activities—from preclinical development through commercial manufacturing—adhere to the highest standards of safety, efficacy, and global regulatory compliance.
This individual will not only manage the existing quality systems but will be instrumental in scaling the quality organization, shaping a robust culture of quality, and ensuring the company is perpetually prepared for regulatory scrutiny and commercial success. This position offers a unique opportunity to make a significant impact on the company’s trajectory and, most importantly, on the lives of patients worldwide.
As a key member of the executive team, you will serve as the company’s chief quality advocate, reporting directly to the Chief Executive Officer. You will be responsible for developing and executing a comprehensive quality strategy that is fully integrated with the company’s corporate objectives. Your leadership will be critical in navigating the complex regulatory landscape associated with advanced biologic therapies.
You will be expected to provide expert guidance on all quality-related matters, influence cross-functional decision-making, and champion a mindset of proactive compliance and continuous improvement throughout every department. The ideal candidate is a seasoned leader with deep experience in the biologics space, a proven track record of building and leading high-performing quality teams, and an unwavering commitment to patient safety and data integrity. This is more than a job; it is a chance to build a legacy of quality within a dynamic organization poised for extraordinary growth.
Key Responsibilities of VP, Quality Assurance with a Biologics Manufacturer – Boston, MA
The Vice President of Quality Assurance will have a broad and impactful scope of responsibilities, encompassing strategic leadership, operational execution, and team development. Success in this role requires a hands-on yet strategic approach to managing the entire quality lifecycle.
Strategic Leadership and Vision
Develop, articulate, and implement a forward-thinking global quality and compliance vision and strategy that aligns with the company’s long-term goals. Serve as the primary quality expert on the senior leadership team, providing critical insights and guidance on compliance risks and opportunities.
Quality Management System (QMS) Architecture and Oversight
Assume ultimate ownership of the company’s QMS. Ensure all elements—including document control, change management, training, deviations, investigations, and CAPA—are robust, scalable, and compliant with global GxP standards. Drive the digital transformation and continuous improvement of QMS processes to enhance efficiency and effectiveness.
Regulatory Compliance and Inspection Readiness
Serve as the primary liaison with global regulatory bodies (FDA, EMA, etc.) on all quality-related matters. Lead the strategy, preparation, execution, and follow-up for all regulatory inspections and audits. Proactively monitor the evolving regulatory landscape to ensure the company remains ahead of new requirements and industry best practices.
Comprehensive GxP Oversight
Provide quality oversight for all stages of product development and commercialization. This includes ensuring compliance across Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Manufacturing Practices (GMP). This oversight extends to internal operations as well as a global network of external partners.
Product Disposition and Release Authority
Hold final responsibility for the quality review and disposition of all raw materials, intermediates, drug substances, and finished drug products for both clinical and commercial use. Ensure that every batch released meets all predefined quality attributes and specifications.
Supplier and Contract Manufacturer (CMO) Quality Management
Design and lead a world-class supplier quality management program. Oversee the qualification, auditing, and ongoing performance monitoring of all contract manufacturing organizations, contract testing laboratories, and critical raw material suppliers to ensure the integrity of the external supply chain.
Team Leadership, Mentorship, and Development
Recruit, lead, and develop a high-caliber, multi-disciplinary Quality Assurance organization. Foster a collaborative and empowering environment that promotes professional growth, accountability, and a shared commitment to a robust quality culture. Manage departmental budgets, resource allocation, and long-range headcount planning.
Data Integrity and Governance
Champion and enforce a stringent data integrity program across all GxP-regulated systems and processes. Ensure that all data generated in support of regulatory submissions and product release is complete, consistent, and accurate.
Cross-Functional Collaboration and Influence
Build strong, collaborative relationships with leaders in Manufacturing, Process Development, Clinical Operations, Regulatory Affairs, and Research. Act as a strategic partner to these functions, providing quality and compliance guidance to facilitate efficient and compliant project execution.
Requirements for the VP, Quality Assurance with a Biologics Manufacturer – Boston, MA
We are seeking an accomplished and dedicated professional who meets the following qualifications to lead our client’s quality function.
Educational Background
An advanced degree (M.S. or Ph.D.) in a relevant scientific or engineering discipline (e.g., Biology, Chemistry, Pharmaceutical Sciences, Biochemical Engineering) is strongly preferred. A B.S. with extensive, directly relevant experience will be considered.
Professional Experience
A minimum of 15 years of progressive experience in Quality Assurance within the biotechnology or pharmaceutical industry is required. At least 8-10 of these years must have been in a senior leadership role with direct management and team-building responsibilities.
Biologics Expertise
Deep, hands-on experience with biologic products is essential. This includes significant exposure to monoclonal antibodies, recombinant proteins, cell therapy, gene therapy, or other advanced therapy medicinal products (ATMPs). Experience taking a biologic product from clinical development through to BLA approval and commercialization is highly desirable.
Regulatory Mastery
Expert-level knowledge and practical application of global regulatory requirements, including U.S. and EU Current Good Manufacturing Practice (cGMP) regulations, as well as GCP and GLP standards. Must have a proven history of successfully leading regulatory inspections by major health authorities (e.g., FDA, EMA).
Technical Acumen
Strong technical understanding of sterile product manufacturing, aseptic processing, analytical and microbiological testing methodologies, process validation, and stability programs specific to biologics.
Leadership and Communication Skills
Demonstrated ability to lead, influence, and motivate across all levels of a scientifically driven organization. Must possess exceptional communication skills (verbal, written, and presentation) and the ability to articulate complex compliance issues in a clear and concise manner to diverse audiences, including executive leadership and board members.
Strategic and Analytical Mindset
Proven ability to think strategically and translate corporate goals into actionable quality objectives. Strong problem-solving and risk-management skills, with a data-driven, pragmatic approach to decision-making.
Cultural Fit
A proactive, results-oriented leader with high integrity and a passion for building a world-class quality culture. Must be comfortable working in a fast-paced, dynamic environment and be able to manage multiple priorities effectively.
Benefits & Perks Offered
Our client believes in investing in their employees and offers a highly competitive and comprehensive benefits package designed to support their team’s professional and personal well-being. This includes:
Competitive Compensation
A highly attractive base salary, significant annual performance-based bonus, and a substantial long-term equity package (stock options/RSUs).
Comprehensive Health and Wellness
Premium medical, dental, and vision insurance plans for employees and their dependents. Generous life insurance, short-term, and long-term disability coverage.
Retirement Planning
A 401(k) retirement savings 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 days, sick leave, and numerous paid company holidays.
Professional Growth
A strong commitment to employee development, with support for attending industry conferences, continuing education, and other professional growth opportunities.
Relocation Support
A comprehensive relocation package is available for exceptional candidates who are not local to the Boston area.
Work Environment
An opportunity to work in a state-of-the-art facility with a collaborative, innovative, and science-focused team dedicated to making a difference.
How to Apply
If you are a visionary Quality leader with the experience and passion to build and lead a premier Quality Assurance function within a groundbreaking biologics company, we want to hear from you. This is a critical hire for our client, and they are prepared to move swiftly for the right candidate.
JRG Partners is proud to partner with this innovative company in their search for this pivotal leadership role. We specialize in connecting top-tier talent with leading organizations in the life sciences sector.
To express your interest in this confidential search, please submit your resume and a cover letter detailing your relevant experience. To learn more about this opportunity and similar executive roles, we invite you to visit the JRG Partners’ Life Sciences and Biotechnology practice page for more information.
