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Quality Operations Supervisor
Actalent
An engineering and sciences services and talent solutions firm connecting specialized experts with industry projects.
Oversee GMP quality operations across sites, manage staff, and ensure compliance.
Lead continuous improvement initiatives to enhance compliance, efficiency, and operational excellence.
Support audit and inspection readiness, and serve as SME during client and regulatory interactions.
Review and approve GMP documentation to ensure compliance and accuracy.
Review and approve deviations, CAPAs, and Change Controls.
Ensure site-wide GMP compliance and product quality.
Supervise, mentor, and develop QO staff.
Apply advanced knowledge of GMP, quality, and risk management to identify and mitigate potential risks or process gaps.
Oversee critical quality activities including apheresis material receipt, production document issuance, batch record review, and final product shipment.
Provide hands-on, on-the-floor QO support in manufacturing cleanrooms, warehouse operations, and QC laboratories.
Serve as the Quality primary point of contact between site operations and QO leadership.
Contribute to continuous improvement of QO processes.
Promote a strong culture of quality, compliance, teamwork, and accountability within the QO team.
Coordinate with cross-functional teams to allocate resources and resolve operational challenges.
What you bring
cell/gene
ms/phd
gmp
capa
aseptic
people management
5+ years of experience in Cell/Gene Therapy OR MS/PhD in a relevant field.
Hands-on experience providing QO support in GMP environments.
Master’s degree with 3–5 years relevant experience preferred.
Flexibility to work shift-based schedules and travel between sites as needed.
Excellent organizational, communication, and problem-solving skills.
Experience with QMS - CAPA investigations and deviations oversight.
Bachelor’s degree in a scientific discipline (Biology, Chemistry, Microbiology, or related) with 5–7 years of experience in GMP/Quality Operations.
Experience with cell and gene therapy manufacturing in clinical or commercial settings.
3+ years of people management experience.
Expertise in aseptic manufacturing processes.
In-depth knowledge of GMPs and ability to apply them in compliance with U.S., EU, and global regulatory standards.
Strong knowledge of GMP, quality systems, and risk management principles.
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