Role Overview for VP, Global Quality Assurance & Control with a Biologics Firm – Boston, MA
JRG Partners is proud to partner with a pioneering, clinical-stage biologics organization at the forefront of developing life-changing therapies. Based in the vibrant biotechnology hub of Boston, MA, our client is dedicated to scientific excellence and innovation. We are seeking a visionary and strategic leader to join their executive team as the Vice President of Global Quality Assurance & Control. This is a paramount role responsible for establishing, maintaining, and championing the global quality vision and strategy across the entire organization.
Reporting directly to the Chief Executive Officer, the VP of Global Quality will be the ultimate authority on product quality and compliance, ensuring that all products meet the highest standards of safety, efficacy, and regulatory compliance worldwide. This executive will provide strategic direction and hands-on leadership for all aspects of the Quality Management System (QMS), including Quality Assurance (QA), Quality Control (QC), and Compliance. The ideal candidate will be a seasoned leader with extensive experience in the biologics space, capable of building and scaling a world-class quality organization that supports a dynamic portfolio from early-phase clinical development through to commercialization. This position requires a leader who can foster a robust culture of quality, act as a key liaison with global regulatory agencies, and drive continuous improvement initiatives that align with the company’s ambitious growth objectives.
Key Responsibilities of VP, Global Quality Assurance & Control with a Biologics Firm – Boston, MA
The Vice President of Global Quality Assurance & Control will be entrusted with a broad range of critical responsibilities, including but not limited to:
Strategic Leadership
Develop, articulate, and execute a comprehensive global quality and compliance strategy that is aligned with the company’s corporate goals and long-term vision. Serve as a key member of the executive leadership team, providing critical input on all quality-related matters.
Quality Management System (QMS) Oversight
Direct the design, implementation, and continuous improvement of a robust, phase-appropriate global QMS. Ensure the QMS is compliant with all applicable global regulations, including those from the FDA, EMA, and other international health authorities.
Regulatory Compliance and Inspections
Serve as the primary point of contact for all regulatory inspections. Lead the preparation for and management of inspections by global health agencies. Ensure all operations adhere to current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
Team Development and Leadership
Build, mentor, and lead a high-performing global Quality organization. Foster a culture of excellence, accountability, and continuous learning. Provide coaching and professional development opportunities to team members to ensure the organization has the necessary skills and capabilities to succeed.
Product Lifecycle Quality
Provide quality oversight for the entire product lifecycle, from preclinical development and clinical trials through to process validation, commercial manufacturing, and post-market surveillance.
Quality Control Leadership
Oversee all Quality Control functions, including analytical method development, validation, stability programs, and release testing for raw materials, in-process materials, and finished biologic products.
Supplier and CMO/CRO Quality Management
Establish and manage a comprehensive supplier quality program. Oversee the qualification, auditing, and performance management of all contract manufacturing organizations (CMOs), contract research organizations (CROs), and critical material suppliers.
Batch Disposition
Hold ultimate responsibility for the review and disposition of all clinical and commercial product batches, ensuring they meet all specifications and regulatory requirements before release.
Risk Management
Implement and maintain a proactive quality risk management program to identify, assess, and mitigate quality and compliance risks across the organization.
Documentation and Data Integrity
Champion a culture of data integrity and ensure all quality-related documentation (e.g., batch records, SOPs, validation protocols) is accurate, complete, and maintained in a state of control.
Budget and Resource Management
Develop and manage the annual budget for the global Quality unit, ensuring optimal allocation of resources to meet strategic objectives.
Cross-Functional Collaboration
Work collaboratively with leaders in Manufacturing, Regulatory Affairs, Clinical Operations, and Research & Development to ensure seamless integration of quality principles throughout the organization.
Requirements for the VP, Global Quality Assurance & Control with a Biologics Firm – Boston, MA
We are seeking an exceptional candidate who meets the following qualifications:
Required Qualifications:
- An advanced degree (M.S., Ph.D., or Pharm.D.) in a relevant scientific discipline such as Biology, Chemistry, Pharmaceutical Sciences, or a related field.
- A minimum of 15 years of progressive experience in the biotechnology or pharmaceutical industry, with at least 10 years in a senior leadership role within Quality Assurance and/or Quality Control.
- Extensive experience with biologics, such as monoclonal antibodies, cell therapies, gene therapies, or vaccines, is mandatory.
- Proven track record of building, leading, and scaling a global Quality organization through various stages of clinical development and commercialization.
- Deep and current knowledge of global regulations and guidelines, including FDA, EMA, and ICH requirements for cGMP, GCP, and GLP.
- Direct, hands-on experience successfully leading multiple regulatory agency inspections (e.g., PAI, general GMP inspections).
- Demonstrated experience in developing and implementing phase-appropriate Quality Management Systems from the ground up.
Preferred Skills and Attributes:
- Exceptional leadership and interpersonal skills with the ability to influence and build consensus across all levels of the organization.
- Strategic thinker with outstanding problem-solving and decision-making capabilities.
- Excellent written and verbal communication skills, with the ability to effectively communicate complex quality and compliance issues to a variety of audiences, including the executive team and Board of Directors.
- Experience with sterile product manufacturing and aseptic processing is highly desirable.
- A strong understanding of quality risk management principles and their practical application.
- A proactive, results-oriented mindset with a strong sense of urgency and a commitment to continuous improvement.
- Ability to thrive in a fast-paced, dynamic, and innovative environment.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier executive talent. The comprehensive compensation and benefits package for this role includes:
Executive Compensation
A highly competitive base salary complemented by a significant annual performance-based bonus.
Equity Participation
A substantial long-term incentive package, including stock options or restricted stock units (RSUs), to ensure you share in the company’s success.
Comprehensive Health Coverage
Premium medical, dental, and vision insurance plans for you and your dependents.
Retirement Savings
A 401(k) plan with a generous company match to help you plan for your future.
Relocation Assistance
A comprehensive executive relocation package is available for the ideal candidate.
Generous Time Off
A flexible and generous paid time off (PTO) policy, in addition to paid company holidays.
Professional Development
A significant budget for professional development, including attendance at key industry conferences, workshops, and executive coaching.
Work Environment
The opportunity to work with a passionate and brilliant team in a state-of-the-art facility located in the heart of Boston’s biotech ecosystem.
How to Apply
This is an exclusive search being conducted by JRG Partners. To be considered for this career-defining opportunity, please submit your resume and a cover letter detailing your qualifications and interest in the role. All applications will be treated with the strictest confidence.
JRG Partners is a leader in executive search for the life sciences sector. We connect innovative companies with the visionary leaders who can drive them forward. To learn more about our expertise and other opportunities, please visit the JRG Partners’ Life Sciences Practice page.
Our client is an Equal Opportunity Employer. They celebrate diversity and are committed to creating an inclusive environment for all employees.
