Site Quality Manager

Site Head of Quality - Maryland & Memphis

CDC are looking for a Site Head of Quality to oversee all aspects of QA and (QC) at a cell therapy CDMO site supporting cell and gene therapy clients. This role defines and executes the site quality vision - ensuring regulatory compliance, client satisfaction, and commercial readiness as the organisation scales rapidly under private equity ownership
.

Responsibilities:

• Serve as the site Quality authority and primary contact for all regulatory agencies.
• Lead the design, implementation, and continuous improvement of the site's QMS tailored to cell therapy processes and phase-appropriate cGMP requirements.
• Oversee QA and QC operations supporting cell therapy manufacturing.
• Provide decisive quality oversight in product release, deviation and CAPA management, change control, and validation - ensuring timely and compliant decision-making.
• Authorise lot disposition decisions and act as the final escalation point for all quality matters at the site.
• Lead readiness for client audits and regulatory inspections.
• Serve as the senior Quality contact for client programs.
• Collaborate with Global Quality and Regulatory teams to ensure consistency.
• Support preparation and review of regulatory submissions and client documentation involving drug substance and drug product manufacturing, validation, and control strategy.
• Partner cross-functionally with Manufacturing, MS&T, Supply Chain, and Business Development to align quality oversight with operational execution, ensuring manufacturing reliability and client satisfaction.
• Lead and sponsor site quality improvement initiatives, digital system implementation, and data integrity enhancements.
• Build and inspire a best-in-class Quality organisation that thrives in a fast-paced, entrepreneurial, and science-driven environment.

Requirements:

• Bachelor's degree in Life Sciences, Engineering, or related discipline required;
  advanced degree (MS, PhD, MBA) preferred.
• Minimum 12 years of progressive Quality leadership experience in biologics or advanced therapies
  , preferred cell therapy manufacturing and Quality experience.
• Proven track record leading a site or major function through clinical-to-commercial transition and licensure readiness
  .
• Deep understanding of global regulatory expectations (FDA, EMA, MHRA, ICH) for viral vector-based products, including contamination control and biosafety requirements.
• Demonstrated experience operating within a CDMO environment
  , balancing client service and compliance with operational and financial performance.
• Strong business acumen and ability to manage within a private equity-backed, growth-oriented structure.
• Excellent communication, negotiation, and leadership skills with the ability to influence across technical and executive teams.
• Experienced in the use of electronic QMS
  , LIMS, and modern analytical data systems;
  Lean Six Sigma certification preferred.