Site Quality Manager

CDC Global Solutions; Maryland; On-site; USD 180,000 - 240,000; Full time

Job summary

CDC Global Solutions is seeking a Site Head of Quality to oversee QA and QC at its Maryland & Memphis cell therapy CDMO site. You will define the site's quality vision and ensure regulatory compliance and client satisfaction as the organization scales.

You will lead QMS design and implementation, authorise dispositions, prepare for audits, and collaborate with Global Quality and Regulatory teams to align quality with operations.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related discipline; advanced degree preferred.
• 12+ years of progressive Quality leadership experience in biologics or advanced therapies.
• 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.
• CDMO experience balancing client service with compliance within a growth-oriented, PE-backed structure.
• Lean Six Sigma certification preferred.

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.
• Authorize 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.

Skills

Regulatory affairs

Quality leadership

cGMP experience

Quality systems

Audit readiness

Cross-functional collaboration

Leadership

cell therapy

Lean Six Sigma

LIMS

Education

Bachelor's degree in Life Sciences or Engineering

MS/PhD or MBA preferred

Tools

LIMS

Electronic QMS

Data integrity tools

Job description

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.