The Bioprocessing QA Manager is responsible for managing Quality Assurance activities in the biologics facility
- Management of the Quality Assurance (Bioprocessing) team, including Qualified Persons.
- The QA Manager will manage batch record reviews, batch disposition and material status control activities associated with the biologics product. These activities will take place 24/7.
- Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
- Management of the Change Control process, ensuring controlled implementation of all GMP related changes.
- Management of QA oversight of manufacturing, testing and relating activities to ensure ongoing cGMP compliance.
- Ensuring effective participation of the Quality Assurance (Bioprocessing) team in production and other site meetings.
- Implementation of Key Performance Indicators within the Quality Assurance area to align with company and global quality objectives.
- Participation in the site Internal Audit programme.
- Participation in the preparation of, and hosting, external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
- Participation in the preparation of documentation for regulatory submission and participation in regulatory affairs discussions.
- The QA Manager will take leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement.
- Implementing efficiency improvements in Quality Dept on a continuous basis and participating in site projects and initiatives.
- Communication and liaison with other departments on Quality issues, providing guidance and support to others.
- Motivation, training, discipline and appraisal of Quality Assurance staff.
- Acting as a designee to the Site Quality Head as required.
- Primary Degree in Scientific discipline with more than 7 years’ experience working an aseptic environment in the pharmaceutical industry, preferably in a Biologics company
- Minimum of 3 years’ experience in a people management role
- Qualified Person status is highly desirable but not essential
- Excellent knowledge of Good Manufacturing Practice for aseptic pharmaceutical manufacture as described in current FDA & EMEA regulations.
- Demonstrable experience managing, motivating and leading a team.
- A high level of initiative is required
- Excellent verbal and written communication skills are essential.
- Strong project management and organisational skills.
- Ability to adapt to changing priorities
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