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.
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