Bachelor's degree in Life Sciences, Chemistry, Biology, Biochemistry, Engineering, or related field
8+ years' experience in GMP-regulated pharmaceutical or biotechnology environments
4+ years' leadership experience in managing QA or Quality Operations teams
Strong expertise in Quality Assurance with batch review and disposition
Experience in cell and gene therapy, viral vectors, or advanced biologics manufacturing
Proven experience in CDMO or multi-client environments
Strong knowledge of GMP processes, aseptic manufacturing, and contamination control
Excellent communication and stakeholder management skills
Responsibilities
Lead and develop a high-performing Quality Operations team in a GMP multi-client environment
Provide strategic oversight of QA across Manufacturing, Warehouse, QC, Supply Chain, and Facilities
Oversee QA support for GMP manufacturing operations and batch record review
Execute batch disposition decisions in line with client agreements and regulatory requirements
Lead quality system activities including deviations, investigations, and CAPAs
Act as primary Quality Operations interface for assigned clients
Support client audits and regulatory inspections, preparing and hosting as necessary
Partner cross-functionally to support tech transfer and operational readiness initiatives
Ensure effective quality oversight of facility operations and monitoring programs
Drive continuous improvement initiatives to enhance performance and efficiency
Benefits
Opportunity to impact the growth of a new CGT CDMO facility
Collaborative work environment partnering with cross-functional teams
Leadership role with potential for significant influence
Engagement in high-stakes compliance and audit activities
Chance to shape and enhance quality systems of a multi-client operation
Full Job Description
We9re currently recruiting for a Senior Manager, Quality Assurance - Operations. This senior leadership role drives Quality Operations excellence across a multi-client GMP environment. You9ll oversee manufacturing quality, batch disposition, and quality systems, while acting as a key interface between teams and clients to ensure compliant, inspection-ready operations. Supporting the growth of a new CGT CDMO facility, you9ll partner cross-functionally to build scalable quality systems and enable operational readiness. playing a key part in advancing our mission and making a real difference.
Your responsibilities in this role would be:
Lead and develop a high-performing Quality Operations team supporting GMP manufacturing, batch disposition, and quality systems within a multi-client CDMO environment.
Provide strategic and operational oversight of QA activities across Manufacturing, Warehouse, QC, Supply Chain, and Facilities to ensure inspection readiness and compliance.
Oversee QA floor support for GMP manufacturing operations, including batch record review, QA holds, and operational walkthroughs.
Execute and support batch disposition decisions aligned with client agreements, regulatory requirements, and product specifications.
Lead and approve quality system activities including deviations, investigations, CAPAs, change controls, and master batch records.
Act as the primary Quality Operations interface for assigned clients, managing Q2Q interactions, communications, and audits.
Support client audits and regulatory inspections, including preparation, hosting, and responses.
Partner cross-functionally with Manufacturing, MSAT, QC, Engineering, and Supply Chain to support tech transfer, validation, and program delivery.
Ensure effective quality oversight of facility operations, environmental monitoring, and contamination control programs.
Drive continuous improvement initiatives to enhance right-first-time performance, reduce deviations, and improve operational efficiency.
We are Looking For:
Bachelor9s degree (or higher) in Life Sciences, Chemistry, Biology, Biochemistry, Engineering, or a related discipline.
8+ years of experience in GMP-regulated pharmaceutical or biotechnology environments.
4+ years of leadership experience managing QA or Quality Operations teams.
Strong expertise in Quality Assurance supporting GMP manufacturing, including batch review and disposition.
Experience in cell and gene therapy, viral vectors, or advanced biologics manufacturing environments.
Proven experience in CDMO or multi-client environments with client-facing quality responsibilities.
Strong knowledge of GMP processes, aseptic manufacturing, environmental monitoring, and contamination control.
Demonstrated ability to build and lead high-performing teams and foster a strong quality culture.
Excellent communication, stakeholder management, and problem-solving skills, with a risk-based decision-making approach.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.
