QA Operations Associate Manager

Our client is a global life science company specialising in cutting edge solutions for biologics, cell and gene therapies driving excellence in manufacturing and quality.

They are currently looking for a QA Operations Associate Manager to manage the day to day QA operations in the manufacturing facility.

Responsibilities:

• Oversee daily Quality Assurance operations and ensure compliance with SOPs and policies in a cell and gene therapy manufacturing environment.
• Act as QA representative during regulatory inspections and client audits, providing front-room and back-room support.
• Serve as a subject matter expert in CGMP and compliance, guiding teams and fostering best practices.
• Identify and resolve quality issues, coordinating corrective and preventive actions across departments.
• Review and approve complex quality decisions, ensuring alignment with regulatory and internal standards.
• Lead planning and prioritization of QA activities for yourself and the team to meet timelines effectively.
• Drive continuous improvement initiatives and contribute to global harmonization projects.
• Manage special projects and propose cost-saving measures to enhance operational efficiency.

Requirements:

• Bachelor's degree in a relevant scientific discipline
• Extensive experience in QA Operations within pharmaceutical or biotech manufacturing
• Strong knowledge of CGMP requirements and quality management systems in a regulated environment.
• Hands-on experience collaborating with cross-functional teams on manufacturing and validation activities.
• Strong people management experience
• Strong communication skills with the ability to influence stakeholders on compliance priorities.

If you are interested, please apply with your CV attached.