Senior QA Operations Leader – GMP & Sterility

Kelly Services; North Carolina; On-site; USD 149,000 - 201,000; Full time

Job summary

Kelly Science in Raleigh, NC is seeking a Senior QA Operations Manager to lead site quality across materials, manufacturing, warehouse, and product release. This role ensures compliance with GMP, data integrity, and regulatory standards while partnering with cross-functional leaders to drive robust processes.

As a member of the Site Quality Leadership Team, you will promote a strong quality culture, support continuous improvement, and translate regulatory expectations into practical, sustainable

Responsibilities

• Provide independent QA oversight and partnership across all operational activities, including incoming materials, warehouse, manufacturing, QC, and product disposition.
• Ensure operational processes are designed and executed in compliance with GMP, ALCOA+ data integrity principles, and internal quality standards.
• Partner with operational leaders to ensure processes are robust, capable of right-first-time execution, and support operational decision-making.
• Ensure timely escalation of significant quality risks to site leadership and the Head of Quality.
• Apply quality risk management principles (ICH Q9) in all operational decision-making.
• Act as a catalyst for a strong quality culture, providing guidance and coaching to operational teams.
• Ensure QA presence in operations through Manufacturing QA and other QA Operations teams.
• Translate regulatory expectations into practical, meaningful practices.
• Promote proactive identification of risks, operational issues, and improvement opportunities.
• Support teams in analyzing situations, addressing root causes, and implementing sustainable improvements.
• Drive continuous improvement initiatives to enhance process robustness and operational performance.
• Oversee batch record review and product disposition processes.
• Ensure robust review processes support compliant and timely product release.
• Assess and address quality issues impacting batch disposition.
• Provide leadership for sterility assurance via the Sterility Assurance function.
• Ensure implementation, maintenance, and continuous improvement of the site Contamination Control Strategy (CCS).
• Oversee contamination control practices, aseptic manufacturing, environmental monitoring, and utilities microbiological risks.
• Ensure compliance with regulatory expectations and industry best practices for sterile product manufacturing.
• Lead QA-driven projects and cross-functional improvement initiatives.
• Promote structured problem solving, risk management and sustainable implementation of improvements.
• Ensure QA support for operational transformations and site-level projects.
• Performs other duties as assigned by management.
• Participate in site initiatives, inspections, audits, and special projects as assigned.
• Support cross-functional initiatives as needed.

Job description

Kelly Science in Raleigh, NC is seeking a Senior QA Operations Manager to lead site quality across materials, manufacturing, warehouse, and product release. This role ensures compliance with GMP, data integrity, and regulatory standards while partnering with cross-functional leaders to drive robust processes.

As a member of the Site Quality Leadership Team, you will promote a strong quality culture, support continuous improvement, and translate regulatory expectations into practical, sustainable