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# VP, Quality Assurance with a Biologics Manufacturer – Raleigh, NC



Role Overview for VP, Quality Assurance with a Biologics Manufacturer – Raleigh, NC
JRG Partners is proud to represent a pioneering biologics manufacturer at the forefront of therapeutic innovation. Located in the vibrant Research Triangle Park area of Raleigh, NC, our client is dedicated to developing and producing life-saving treatments that address unmet medical needs globally. We are seeking a visionary and strategic executive to join their leadership team as the Vice President of Quality Assurance. This is a pivotal role responsible for architecting and executing the comprehensive quality and compliance strategy across the entire organization.
The VP of Quality Assurance will be the ultimate authority on product quality, patient safety, and regulatory compliance. This individual will provide transformative leadership to the Quality organization, fostering a robust culture of quality that is embedded in every facet of the company’s operations, from early-stage development through commercial manufacturing. You will be instrumental in ensuring that all products meet the highest standards of safety, efficacy, and purity, in strict accordance with global regulatory requirements.
This role demands a leader who can balance strategic, long-term vision with hands-on, tactical execution. You will be a key partner to the executive team, providing critical insights and guidance on all quality-related matters that impact business objectives, risk management, and market expansion. Your leadership will directly influence the company’s reputation, operational excellence, and its ability to successfully bring innovative biologic therapies to patients worldwide.
This position offers a unique opportunity to shape the future of a dynamic, high-growth organization. The ideal candidate will be a seasoned quality professional with extensive experience in the biologics space, a proven track record of leading successful regulatory inspections, and a passion for building and mentoring world-class teams. If you are a strategic thinker with an unwavering commitment to quality and a desire to make a significant impact in the biopharmaceutical industry, we invite you to explore this exceptional career opportunity.
Key Responsibilities of VP, Quality Assurance with a Biologics Manufacturer – Raleigh, NC
Strategic Leadership and Vision
Develop, articulate, and implement a forward-thinking, multi-year quality strategy that aligns with the company’s corporate goals and long-range plans. Serve as a key member of the senior leadership team, providing expert counsel on quality, compliance, and risk management. Champion a proactive, phase-appropriate quality culture throughout the organization.
Global Regulatory Compliance
Ensure unwavering compliance with all applicable global health authority regulations, including FDA, EMA, and other international bodies. Maintain expert-level knowledge of current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP). Act as the primary point of contact for regulatory agencies and lead the organization through all inspections and audits, ensuring successful outcomes.
Quality Management System (QMS) Oversight
Provide executive oversight for all elements of the Pharmaceutical Quality System (PQS). This includes, but is not limited to, CAPA (Corrective and Preventive Actions), change control, deviation and investigation management, document control, training programs, supplier quality management, and data integrity governance. Drive continuous improvement and optimization of the QMS to enhance efficiency and effectiveness.
Product Lifecycle Quality
Direct all Quality Assurance activities supporting the entire product lifecycle, from preclinical development and clinical trials to process validation, commercial manufacturing, and post-market surveillance. Oversee lot release and disposition activities for all clinical and commercial products, ensuring they meet all specifications and quality attributes.
Team Leadership and Development
Lead, mentor, and develop a high-performing, multi-disciplinary Quality organization, including Quality Assurance, Quality Control, Quality Systems, and Compliance. Foster a collaborative and empowering environment, setting clear objectives, providing regular feedback, and managing talent development to build a robust leadership pipeline.
Cross-Functional Collaboration
Build and maintain strong, collaborative relationships with leaders in Manufacturing, Process Development, Regulatory Affairs, Clinical Operations, and Supply Chain. Work seamlessly with these partners to resolve complex quality issues, facilitate technology transfer, and ensure that quality is built into all processes from the start.
Risk Management
Establish and maintain a comprehensive quality risk management program. Proactively identify, assess, and mitigate quality and compliance risks across the GxP landscape. Ensure that risk-based decision-making is integrated into all aspects of the QMS.
Operational Excellence
Drive a culture of continuous improvement within the Quality unit and across the site. Utilize metrics, KPIs, and quality trend analysis to monitor performance, identify areas for improvement, and implement effective solutions that enhance compliance and operational efficiency. Prepare and manage the annual budget for the Quality department.
Requirements for the VP, Quality Assurance with a Biologics Manufacturer – Raleigh, NC
Educational Background
An advanced degree (M.S., Ph.D., or Pharm.D.) in a relevant scientific discipline such as Biology, Chemistry, Biochemistry, or Pharmaceutical Sciences is required.
Executive Experience
A minimum of 15 years of progressive experience in the pharmaceutical or biotechnology industry, with at least 7-10 years in a senior leadership role (Director, Senior Director, or VP) with direct management of a significant Quality Assurance organization.
Biologics Expertise
Extensive, hands-on experience with the quality and compliance requirements for biologic products is mandatory. This includes experience with monoclonal antibodies, recombinant proteins, cell therapies, gene therapies, or vaccines. Deep knowledge of aseptic processing, sterile manufacturing, and associated validation principles is essential.
Regulatory Mastery
Proven experience successfully hosting and leading regulatory inspections by the FDA and other major international health authorities (e.g., EMA, PMDA). Must possess a deep and practical understanding of global cGMP regulations (e.g., 21 CFR 210/211, 600/610, 820; Eudralex Volume 4).
Leadership Acumen
Demonstrated ability to lead, influence, and motivate a large and diverse team. A track record of developing talent and building a strong, positive, and accountable quality culture. Must possess exceptional strategic thinking, problem-solving, and decision-making skills.
Communication Skills
Outstanding written and verbal communication skills. The ability to effectively communicate complex technical and regulatory issues to a wide range of audiences, from the manufacturing floor to the Board of Directors.
Business Insight
Strong business acumen with the ability to translate quality and compliance requirements into pragmatic, business-oriented solutions. Experience with budget management and resource planning is required.
Location
The candidate must be willing and able to work on-site in the Raleigh, NC area. Relocation assistance is available for an exceptional candidate.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a highly competitive and comprehensive compensation and benefits package. As a key member of the executive team, you can expect:
Competitive Executive Compensation
A highly attractive 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 & Wellness
Premium medical, dental, and vision insurance plans for you and your eligible dependents, with low employee contributions. Health Savings Account (HSA) and Flexible Spending Account (FSA) options are also available.
Retirement Savings
A robust 401(k) plan with a generous company match to help you plan for your future.
Generous Paid Time Off
A flexible and generous paid time off (PTO) policy, including vacation, sick leave, and numerous paid holidays.
Relocation Assistance
A comprehensive relocation package is available for the selected candidate and their family.
Professional Development
A strong commitment to your continued growth, with support for attending industry conferences, executive coaching, and further education.
Work-Life Balance
A culture that respects and promotes a healthy balance between professional responsibilities and personal life.
How to Apply
JRG Partners is exclusively managing the search for this critical VP, Quality Assurance position. We are looking for a transformative leader who is ready to make a lasting impact on a mission-driven organization.
If you meet the qualifications and are excited by the opportunity to lead the quality function for an innovative biologics company, we encourage you to submit your application. To be considered, please apply through our dedicated portal. For more information about our expertise in this sector, please visit our Life Sciences Recruiting Practice Area page.
JRG Partners and our client are Equal Opportunity Employers. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.