Role Overview for Head of Aseptic Quality with a Biologics CDMO–Wilson, NC
JRG Partners is proud to partner with a leading-edge Biologics Contract Development and Manufacturing Organization (CDMO) in their search for a visionary and strategic Head of Aseptic Quality. This pivotal executive leadership role, based at their state-of-the-art facility in Wilson, NC, is responsible for the overall strategy, direction, and execution of all aseptic quality assurance and quality control functions. As the site’s ultimate authority on sterile product quality, you will be instrumental in safeguarding patient safety, ensuring product integrity, and maintaining the highest standards of regulatory compliance.
This is a unique opportunity to shape the quality culture of a rapidly growing organization that is at the forefront of biologic drug substance and drug product manufacturing. The Head of Aseptic Quality will serve as a key member of the site leadership team, providing expert guidance on all matters related to aseptic processing, environmental monitoring, sterility assurance, and cGMP compliance. You will lead a dedicated team of quality professionals, fostering an environment of accountability, continuous improvement, and scientific excellence. Your leadership will directly impact the company’s ability to deliver life-saving therapies for a diverse portfolio of global clients, from emerging biotechs to large pharmaceutical partners. You will be the face of quality for the site, interacting with clients and regulatory agencies, and championing a ‘quality-first’ mindset across all operational functions. This role requires a dynamic leader who can balance strategic long-term planning with hands-on, tactical execution in a fast-paced, multi-product environment.
Key Responsibilities of Head of Aseptic Quality with a Biologics CDMO–Wilson, NC
The Head of Aseptic Quality will have a broad and impactful scope of responsibilities, including but not limited to:
Strategic Leadership & Department Management
Develop and execute a comprehensive site quality strategy for aseptic operations. Lead, mentor, and develop a high-performing team of Quality Assurance professionals, setting clear objectives and managing performance. Oversee departmental budgeting, resource allocation, and long-range capacity planning to support business growth.
Regulatory Compliance & Inspection Readiness
Serve as the primary subject matter expert for aseptic quality during regulatory inspections (FDA, EMA, PMDA, etc.) and client audits. Ensure all site operations, procedures, and systems related to sterile manufacturing are in a constant state of inspection readiness and fully compliant with global Current Good Manufacturing Practice (cGMP) regulations, including 21 CFR 210/211, Annex 1, and ICH guidelines.
Quality Systems Oversight
Provide ultimate oversight and approval for all critical quality systems supporting aseptic manufacturing. This includes, but is not limited to, deviation management, CAPA (Corrective and Preventive Actions), change control, batch record review and disposition, risk management (QRM), and supplier quality management. Ensure these systems are robust, efficient, and effective in maintaining product quality and compliance.
Sterility Assurance & Contamination Control
Champion the site’s Contamination Control Strategy (CCS). Provide expert oversight of the environmental monitoring (EM) and utility monitoring programs for ISO-classified manufacturing areas. Ensure robust aseptic process simulations (media fills) are designed and executed flawlessly. Review and approve validation protocols and reports for sterilization processes (e.g., autoclave, VHP).
Batch Disposition & Investigations
Hold final responsibility for the review and disposition of all sterile drug product batches manufactured at the site. Lead or oversee complex investigations into critical deviations, out-of-specification (OOS) results, and potential sterility failures, ensuring thorough root cause analysis and effective corrective actions are implemented to prevent recurrence.
Cross-Functional Collaboration & Client Engagement
Act as a strategic partner to Manufacturing, Engineering, and MS&T (Manufacturing, Science, and Technology) departments to proactively identify and mitigate quality risks. Foster a collaborative environment to ensure quality is built into processes from development through commercial production. Serve as the senior quality liaison for clients, building trust and ensuring their quality requirements are met and exceeded.
Continuous Improvement
Drive a culture of continuous improvement within the Quality unit and across the site. Utilize quality metrics, trend analysis, and data-driven insights to identify opportunities for enhancing quality systems, improving process robustness, and increasing operational efficiency. Sponsor and lead key quality improvement projects and initiatives.
Requirements for the Head of Aseptic Quality with a Biologics CDMO–Wilson, NC
The ideal candidate will be an accomplished quality leader with deep technical expertise in aseptic manufacturing and a proven track record of success in the biopharmaceutical industry.
Educational Background
A minimum of a Bachelor of Science (B.S.) degree in a relevant life science field (e.g., Microbiology, Biology, Biochemistry, Chemistry) is required. An advanced degree (M.S. or Ph.D.) is highly preferred.
Professional Experience
A minimum of 15+ years of progressive experience within the pharmaceutical or biotechnology industry, with at least 10 years in a Quality Assurance or Quality Control leadership role. A minimum of 7 years of direct management experience, leading and developing teams of quality professionals, is essential.
Technical Expertise
Must possess extensive, hands-on experience and in-depth knowledge of aseptic processing, sterile fill-finish operations, isolator technology, and biologics manufacturing. Deep understanding of microbiology, sterility assurance principles, and environmental monitoring is non-negotiable.
Regulatory Acumen
Demonstrated expert-level knowledge of global cGMP regulations and guidelines pertaining to sterile products (e.g., FDA 21 CFR 210/211, EU GMP Annex 1, ICH Q7/Q8/Q9/Q10). Proven experience successfully hosting multiple regulatory agency inspections is required.
Leadership Skills
Exceptional leadership, interpersonal, and communication skills. Ability to influence and build consensus across all levels of the organization. A proven history of building, developing, and retaining high-performing teams.
CDMO Experience
Prior experience working in a Contract Development and Manufacturing Organization (CDMO) or a multi-product commercial manufacturing environment is strongly preferred.
Problem-Solving & Critical Thinking
Strong analytical and problem-solving abilities with a demonstrated capacity for making sound, risk-based quality decisions in a fast-paced environment.
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 Compensation
An attractive base salary complemented by a significant annual performance-based bonus and long-term incentive plan (equity/stock options).
Comprehensive Health & Wellness
A robust benefits package including premium medical, dental, and vision insurance for you and your dependents.
Retirement Savings
A 401(k) retirement plan with a generous company match to help you plan for your future.
Work-Life Balance
A generous Paid Time Off (PTO) policy, including vacation, sick leave, and paid company holidays.
Relocation Support
A comprehensive relocation package is available for qualified candidates to facilitate a smooth transition to the Wilson, NC area.
Professional Growth
Ample opportunities for professional development, including support for attending industry conferences, workshops, and continuing education.
Impactful Work
The opportunity to play a critical role in a dynamic, high-growth company that is manufacturing therapies that change patients’ lives.
How to Apply
This is a retained search exclusively managed by JRG Partners. If you are a transformative quality leader with the expertise and passion to excel in this critical role, we encourage you to apply. To be considered for this exceptional opportunity, please submit your resume and a cover letter detailing your qualifications and interest.
For more information or to discuss your suitability for this or other executive-level opportunities in the biotechnology and pharmaceutical sectors, we invite you to connect with JRG Partners’ Aseptic Manufacturing, Injectable Production & Sterile Operations search team. We are dedicated to connecting top-tier talent with industry-leading organizations. Your inquiry will be handled with the utmost confidentiality. We look forward to hearing from you.
