Role Overview for VP, Global Quality with a Biologics Manufacturer – Boston, MA
JRG Partners is proud to partner with a pioneering, research-driven biologics manufacturer in the search for an exceptional Vice President of Global Quality. Located in the heart of the Boston, MA biotechnology hub, our client is at the forefront of developing life-changing therapies for patients with unmet medical needs. This is a paramount executive leadership position responsible for establishing and executing the global quality vision, strategy, and operations across the entire organization. The VP, Global Quality will serve as the ultimate authority on product quality and regulatory compliance, ensuring that all products meet the highest standards of safety, efficacy, and purity from early-stage development through commercialization and post-market activities.
This role is not merely about compliance; it is about championing a proactive, deeply embedded culture of quality that permeates every function of the company. The ideal candidate will be a strategic, forward-thinking leader with a profound understanding of the complexities of biologics manufacturing and global regulatory landscapes. You will be responsible for leading, mentoring, and inspiring a large, multi-site team of quality professionals, driving operational excellence, and fostering an environment of continuous improvement. As a key member of the executive leadership team, you will collaborate closely with leaders in Manufacturing, R&D, Regulatory Affairs, and Clinical Operations to ensure that quality objectives are seamlessly integrated with and actively support the company’s ambitious business goals. Your leadership will be critical in navigating the challenges of a rapidly growing pipeline, scaling operations, and maintaining an impeccable record with global health authorities.
Key Responsibilities of VP, Global Quality with a Biologics Manufacturer – Boston, MA
Strategic Quality Leadership
Develop, articulate, and implement a comprehensive global quality vision and multi-year strategy that aligns with the company’s corporate objectives. Provide executive leadership and direction for all Quality Assurance (QA) and Quality Control (QC) functions worldwide.
Global Quality Management System (QMS) Oversight
Direct the design, implementation, and continuous enhancement of a robust, phase-appropriate global QMS. Ensure the QMS is compliant, efficient, and scalable to support products throughout their lifecycle, including management of document control, training programs, CAPA, change control, risk management, and supplier quality.
Regulatory Compliance and Inspection Management
Serve as the primary point of contact and host for inspections by global regulatory agencies, including the FDA, EMA, PMDA, and others. Ensure unwavering compliance with all applicable global regulations, standards, and guidelines, including current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
Team Development and Leadership
Lead, mentor, and develop a high-performing, globally dispersed quality organization. Foster a culture of accountability, collaboration, and excellence. Attract and retain top-tier talent to build a world-class quality team.
Operational Excellence and Continuous Improvement
Champion a mindset of continuous improvement across the organization. Establish, monitor, and report on key quality metrics and performance indicators (KPIs) to drive efficiency and effectiveness. Implement best-in-class quality systems and processes to mitigate risk and enhance product quality.
Product Lifecycle Quality Oversight
Provide strategic quality input and oversight for all stages of the product lifecycle, from preclinical and clinical development, through process validation and commercial manufacturing, to post-market surveillance. Ensure quality-by-design (QbD) principles are integrated early in development.
Audit Program Management
Oversee a comprehensive internal and external audit program to ensure compliance of all internal sites, contract manufacturing organizations (CMOs), contract research organizations (CROs), and critical suppliers. Ensure timely resolution of audit findings.
Executive Collaboration and Partnership
Act as a strategic partner to the executive team, providing expert quality and compliance counsel. Collaborate effectively with Manufacturing, Supply Chain, R&D, and Regulatory Affairs to resolve complex issues and ensure alignment on quality and business priorities.
Budget and Resource Management
Develop and manage the annual budget for the Global Quality department, ensuring optimal allocation of resources to meet strategic objectives and operational demands.
Requirements for the VP, Global Quality with a Biologics Manufacturer – Boston, MA
Educational Background
An advanced degree (M.S., Ph.D., Pharm.D.) in Chemistry, Biology, Pharmacy, or a related life sciences discipline is required.
Executive Experience
A minimum of 15-20 years of progressive, hands-on experience in Quality Assurance and/or Quality Control within the biotechnology or pharmaceutical industry. At least 10 years of experience in a senior leadership capacity (Director level or above) with responsibility for managing large, multi-site teams.
Technical Expertise in Biologics
Extensive, in-depth experience with a range of biologic modalities, such as monoclonal antibodies (mAbs), cell and gene therapies, recombinant proteins, or vaccines. Deep knowledge of aseptic processing, sterile manufacturing, analytical method development/validation, and stability programs is essential.
Global Regulatory Mastery
Proven track record of successfully leading and managing regulatory inspections from major global health authorities (FDA, EMA, etc.). Expert-level understanding of global cGMP, GCP, and GLP regulations and ICH guidelines.
Demonstrated Leadership Acumen
A strategic and visionary leader with the proven ability to build, lead, and motivate high-performance teams. Must possess exceptional decision-making skills, business acumen, and the ability to influence across all levels of an organization.
Communication and Interpersonal Skills
Impeccable written and verbal communication skills. The ability to articulate complex quality and compliance issues clearly and concisely to technical and non-technical audiences, including executive leadership and board members.
Problem-Solving Skills
Strong analytical and critical thinking skills with a demonstrated ability to navigate and resolve complex quality challenges in a fast-paced, dynamic environment.
Location and Travel
The position is based in the greater Boston, MA area and requires a significant on-site presence. Willingness and ability to travel domestically and internationally up to 25% as needed.
Benefits & Perks Offered
Our client is committed to investing in their employees and offers a highly competitive and comprehensive compensation and benefits package for this executive role, including:
- Highly competitive base salary and an attractive annual executive bonus program.
- Significant long-term incentives, including stock options and/or restricted stock units (RSUs).
- Comprehensive health, dental, vision, and life insurance plans for you and your dependents.
- A robust 401(k) retirement savings plan with a generous company match.
- Generous paid time off (PTO), including vacation, sick leave, and company holidays.
- A comprehensive relocation assistance package for qualified candidates.
- Support for professional development, including attendance at industry conferences and continuing education.
- Access to company wellness programs and other employee-centric perks.
How to Apply
JRG Partners is the exclusive recruitment partner for this critical executive search. If you are a transformative quality leader with the experience and passion to drive excellence at a leading biologics organization, we invite you to apply for this confidential opportunity. Please submit your curriculum vitae and a detailed cover letter outlining your suitability for the role. To learn more about our specialized recruitment expertise in this sector, please visit our Life Sciences & Biotechnology Practice page. JRG Partners is an equal opportunity employer and values diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
