Role Overview for VP, Global Quality Assurance with a Vaccine Manufacturer – Raleigh, NC
JRG Partners is proud to represent a pioneering, research-driven vaccine manufacturer in their search for a visionary Vice President of Global Quality Assurance. This is a paramount executive leadership position based in the vibrant life sciences hub of Raleigh, North Carolina. Our client is at the forefront of developing and commercializing next-generation vaccines that address critical global health challenges. The individual who steps into this role will not just lead a department; they will be the ultimate steward of quality and compliance for the entire organization, ensuring that every product released meets the highest standards of safety, efficacy, and regulatory integrity.
As the VP of Global Quality Assurance, you will be a key member of the executive leadership team, reporting directly to the Chief Executive Officer. You will be entrusted with the strategic direction and operational execution of all quality assurance and compliance functions across the globe. This encompasses the full product lifecycle, from preclinical research (GLP) and clinical trials (GCP) to commercial manufacturing (GMP) and post-market surveillance (GVP). Your leadership will be instrumental in shaping a proactive, world-class quality culture that permeates every facet of the organization. You will build, mentor, and inspire a global team of quality professionals, empowering them to drive continuous improvement and uphold the company’s unwavering commitment to patient safety. This role requires a strategic thinker with a hands-on approach, capable of navigating the complex and ever-evolving global regulatory landscape for biologics and vaccines.
Key Responsibilities of VP, Global Quality Assurance with a Vaccine Manufacturer – Raleigh, NC
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 implement a comprehensive global quality and compliance strategy that aligns with the company’s corporate objectives and long-term growth plans. Serve as the leading voice for quality on the executive team, providing strategic guidance on risk management and compliance matters.
Global Regulatory Compliance
Guarantee that all company operations, from R&D to commercialization, are in strict compliance with global GxP regulations. Ensure all operations adhere to the stringent standards for biologics regulated products as defined by the FDA, EMA, PMDA, WHO, and other relevant health authorities. Act as the primary liaison with regulatory agencies during inspections and inquiries, fostering transparent and positive relationships.
Quality Management System (QMS) Oversight
Direct the architecture, implementation, and continuous improvement of a robust, phase-appropriate global QMS. This includes overseeing all critical systems such as Document Control, Employee Training, CAPA (Corrective and Preventive Actions), Change Control, Deviation and Investigation Management, and Management Review.
Audit and Inspection Management
Lead and manage a comprehensive internal and external audit program to ensure the compliance of internal sites, contract manufacturing organizations (CMOs), contract research organizations (CROs), and critical suppliers. Expertly prepare for and host regulatory agency inspections, ensuring successful outcomes.
Product Disposition and Lifecycle Oversight
Hold ultimate accountability for the quality oversight and disposition of all clinical and commercial product batches. Provide strategic quality input for all stages of the product lifecycle, including process development, technology transfer, validation, and commercial production of sterile vaccine products.
Team Development and Leadership
Recruit, develop, and retain a high-performing, multi-disciplinary global quality assurance team. Provide strong mentorship, coaching, and performance management to foster a culture of excellence, collaboration, and professional growth. Structure the department for scalability and future success.
Supplier and Vendor Quality Management
Establish and maintain a rigorous supplier quality management program. This involves the qualification, monitoring, and auditing of all GxP vendors, suppliers, and service providers. Ensure robust Quality Agreements are negotiated and maintained with all critical partners.
Data Integrity and System Validation
Champion and enforce a culture of data integrity across the entire organization. Oversee the validation and compliance of all computerized systems (CSV) used in GxP environments, ensuring they are fit for purpose and meet regulatory expectations.
Budgetary and Financial Responsibility
Develop, justify, and manage the annual budget for the Global Quality Assurance department. Ensure prudent financial management and optimal allocation of resources to achieve strategic quality objectives.
Cross-Functional Collaboration
Partner effectively with leaders across Manufacturing, Supply Chain, Regulatory Affairs, Clinical Operations, and Research & Development to integrate quality principles into all business processes. Drive resolution of complex quality issues in a collaborative and efficient manner.
Requirements for the VP, Global Quality Assurance with a Vaccine Manufacturer – Raleigh, NC
The ideal candidate will be a seasoned quality leader with extensive experience in the biologics and vaccine space. They will possess a unique blend of technical expertise, strategic acumen, and inspirational leadership.
Educational Background
An advanced degree (M.S., Ph.D., or Pharm.D.) in a relevant scientific field such as Biology, Chemistry, Microbiology, Pharmaceutical Sciences, or a related discipline is required.
Professional Experience
A minimum of 15 to 20 years of progressive experience within the biotechnology or pharmaceutical industry, with a clear focus on quality assurance and regulatory compliance. At least 10 of these years must have been in a senior leadership capacity (Director level or above) with responsibility for managing large, multi-site or global teams.
Technical Expertise
- Mandatory, in-depth experience with biologics is essential. Specific, hands-on experience with the development, manufacturing, and quality control of vaccines is highly preferred.
- Demonstrated expertise in sterile product manufacturing, aseptic processing, and environmental monitoring.
- Comprehensive understanding and practical application of global GxP regulations (cGMP, GCP, GLP, GVP) and guidelines (ICH, etc.).
Leadership and Management Skills
- Proven track record of building, leading, and mentoring high-performance quality assurance organizations.
- Exceptional strategic thinking and problem-solving skills, with the ability to navigate ambiguity and make sound decisions under pressure.
- Outstanding communication skills (written and verbal) with the ability to effectively communicate complex technical and regulatory issues to a variety of audiences, including executive leadership and regulatory bodies.
- Strong influencing and negotiation skills, with a demonstrated ability to foster collaboration and drive consensus across diverse functional groups.
Regulatory Interaction Experience
Extensive, first-hand experience leading interactions with major global regulatory agencies, including the FDA and EMA. Must have a proven history of successfully preparing for and managing Pre-Approval Inspections (PAIs) and other GxP inspections.
Personal Attributes
A person of high integrity, with a strong commitment to ethics and patient safety. A proactive, results-oriented leader who is passionate about building a robust culture of quality. Must be willing and able to be on-site in Raleigh, NC.
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 competitive base salary complemented by a significant annual performance-based bonus and a substantial long-term incentive package (equity/stock options).
Comprehensive Health & Wellness
Premium medical, dental, and vision insurance plans for you and your eligible dependents. Robust wellness programs and resources.
Retirement Savings
A generous 401(k) retirement plan with a strong company matching contribution.
Work-Life Balance
A substantial paid time off (PTO) policy, including vacation, sick leave, and company-paid holidays.
Relocation Support
A comprehensive relocation assistance package is available for the successful candidate and their family.
Professional Growth
Ample opportunities for continued professional development, including support for attending industry conferences and executive education programs.
Impactful Mission
The unique opportunity to play a pivotal role in a dynamic, mission-driven organization dedicated to improving global health through vaccine innovation.
How to Apply
This is a retained search being conducted exclusively by JRG Partners. If you are a transformative quality leader with the requisite experience and a passion for advancing vaccine manufacturing, we encourage you to apply. All inquiries and applications will be handled with the strictest confidence.
To express your interest in this executive opportunity, please connect with our specialized recruitment team. You can learn more about our expertise in this sector by visiting our Life Sciences and Pharmaceutical Practice Area page. We look forward to discussing how your background aligns with this critical leadership role.
