Role Overview for VP, Global Quality Assurance with a Biologics Manufacturer – Boston, MA
JRG Partners is proud to partner exclusively with a pioneering, commercial-stage biologics manufacturer in their search for a transformative Vice President of Global Quality Assurance. Located in the vibrant heart of the Boston, MA biotechnology ecosystem, our client is at the forefront of developing and commercializing life-changing therapies for patients with critical unmet medical needs. This is a rare opportunity to join a dynamic senior leadership team and shape the future of quality and compliance for a rapidly growing organization.
As the VP of Global Quality Assurance, you will be the ultimate authority on quality, providing strategic direction and operational oversight for all quality assurance and compliance functions across the global enterprise. Reporting directly to the Chief Operating Officer, you will be responsible for designing, implementing, and maintaining a robust, scalable, and world-class Quality Management System (QMS) that ensures the highest standards of product quality, patient safety, and regulatory compliance. Your leadership will be pivotal in fostering a proactive and deeply embedded culture of quality, enabling the company to navigate complex global regulatory landscapes while successfully advancing its diverse pipeline of biologic products from clinical development through to commercialization. This executive role demands a visionary leader who can balance strategic thinking with hands-on execution, driving continuous improvement and ensuring that quality is a competitive advantage for the business.
Key Responsibilities of VP, Global Quality Assurance with a Biologics Manufacturer – Boston, MA
The VP, Global Quality Assurance will have a broad and impactful scope of responsibilities, including but not limited to:
Strategic Leadership and Vision
Develop, articulate, and execute a comprehensive global quality and compliance strategy that is fully aligned with the company’s corporate objectives and long-range plans. Serve as a key member of the senior leadership team, providing expert counsel on all quality-related matters and contributing to overall business strategy. Champion a culture of quality excellence, accountability, and continuous improvement that permeates every level of the organization.
Global Quality Systems (QMS) Management
Assume ultimate ownership for the architecture, implementation, and lifecycle management of a robust, GxP-compliant global Quality Management System. This includes overseeing all critical subsystems such as Document Control, Change Management, Employee Training, Deviation and Investigation Management, Corrective and Preventive Actions (CAPA), and Management Review. Ensure the QMS is efficient, effective, and appropriately scaled for a multi-product, commercial-stage company.
Regulatory Compliance and Inspection Readiness
Act as the primary point of contact and lead host for all global health authority inspections (e.g., FDA, EMA, PMDA). Guarantee that all sites, systems, and personnel are in a constant state of inspection readiness. Proactively monitor the evolving global regulatory environment, interpret new regulations and guidances, and direct the implementation of necessary changes to maintain compliance. Provide quality oversight and review for all major regulatory submissions, including INDs, BLAs, and MAAs.
Operational Quality Oversight
Provide comprehensive QA oversight for all GxP activities across the product lifecycle. This includes quality assurance for internal and external manufacturing (CMOs), supply chain, quality control laboratories (internal and external), and clinical operations (GCP). Lead the product disposition process, ensuring timely and compliant review of batch records and associated documentation for the release of all clinical and commercial products.
Supplier and CMO Quality Management
Direct the supplier quality management program, ensuring all external partners, including Contract Manufacturing Organizations (CMOs) and Contract Testing Laboratories (CTLs), meet the company’s stringent quality standards. Oversee the qualification, auditing, and ongoing performance monitoring of all GxP vendors. Negotiate and maintain robust Quality Agreements with all critical partners.
Team Leadership and Organizational Development
Build, lead, mentor, and develop a world-class global Quality Assurance organization. Attract and retain top talent, fostering an environment of collaboration, professional growth, and high performance. Establish departmental goals, manage budgets, and allocate resources effectively to support corporate priorities.
Requirements for the VP, Global Quality Assurance with a Biologics Manufacturer – Boston, MA
The ideal candidate will be a seasoned quality leader with a proven track record of success in the biopharmaceutical industry.
Educational Background
An advanced degree (M.S., Ph.D., or equivalent) in a relevant scientific or engineering discipline (e.g., Biology, Chemistry, Pharmaceutical Sciences) is required.
Professional Experience
A minimum of 15 years of progressive experience in Quality Assurance within the biotechnology or pharmaceutical industry, with a strong focus on biologics (e.g., monoclonal antibodies, cell/gene therapies, vaccines). At least 8-10 years of experience in a senior leadership role (e.g., Senior Director, Vice President) with responsibility for managing global teams and functions.
Regulatory Expertise
Demonstrated experience successfully leading multiple regulatory GxP inspections by major global health authorities, including the FDA and EMA. Must possess an expert understanding of global Good Manufacturing Practices (GMP), as well as GCP, GLP, and GVP regulations and associated ICH guidelines.
Technical Acumen
Deep technical expertise in biologics manufacturing, aseptic processing, analytical development, and validation is essential. Extensive experience providing quality oversight for both internal manufacturing sites and a global network of CMOs is required.
Leadership Competencies
Exceptional strategic thinking, problem-solving, and decision-making skills. Proven ability to build and lead high-performing teams and to foster a strong, proactive quality culture. Must possess outstanding communication, interpersonal, and influencing skills, with the ability to effectively engage with executive leadership, cross-functional teams, and external regulatory bodies. Experience with change management and scaling quality systems in a high-growth environment is highly preferred.
Benefits & Perks Offered
Our client is committed to attracting and retaining the best talent in the industry and offers a highly competitive compensation and benefits package, including:
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 you and your dependents. A robust wellness program, including gym membership reimbursement and mental health resources.
Financial Security
A 401(k) retirement savings plan with a generous company match. Company-paid life insurance and disability coverage.
Work-Life Balance
A generous paid time off (PTO) policy, including vacation, sick days, and company holidays. Paid parental leave to support growing families.
Professional Growth
A dedicated budget for professional development, including attendance at industry conferences, workshops, and continuing education courses.
Relocation Support
A comprehensive relocation package is available for exceptional candidates who are not local to the Boston area.
How to Apply
JRG Partners is the exclusive recruitment partner for this critical leadership position. If you are a visionary quality leader with the experience and passion to make a significant impact on patient lives, we encourage you to apply. Please submit your resume and a cover letter for confidential consideration. To learn more about our dedicated recruitment services, please explore our expertise in Life Sciences executive search. We look forward to connecting with you to discuss this transformative opportunity.
