We are currently seeking a full-time QA Compliance Manager to join our Quality Assurance department, reporting directly to the Head of Quality. In this pivotal role, you will lead a dynamic team dedicated to supporting the organisation in achieving cGMP certification.
This is an exciting time to join the company, as we are undergoing significant transformation across key areas of our organisation. For candidates with the right experience, there may be an opportunity to join a sponsorship programme leading to QP qualification—an exciting pathway for professional growth within the organisation.
The successful candidate will oversee the development, implementation and maintenance of quality assurance systems and activities. Selects, develops and evaluates personnel to ensure the efficient operation of the function.
In addition you will:
- Ensure batch records for biological drug substance are reviewed prior to Qualified Person (QP) release
- Monitor compliance with the requirements of Good Manufacturing Practice (GMP)
- Review and assess the quality impact of any deviations prior to review and release of product by QP
- Responsible for coordination and preparation of Quality Management Review, including Key Performance Indicator (KPI) information and analysis of trends
- Management of self-inspection/internal audit and its program, including coordinating and conducting regular audits to assess compliance to EudraLex – Volume 4 – GMP guidelines and other applicable quality system requirements
- Prepare audit reports and raise non-compliance notices for areas which need improvement
- Management of the internal non-conformance management systems; specifically Corrective and Preventive Actions (CAPA’s), Deviations, and Supplier Corrective Action Requests
- Ensure Quality Induction training is given to new starters and Current Good Manufacturing Practice (cGMP) training to departments is coordinated
- Host, coordinate, and participate in customer audits
- Deputize for the Director of Quality for approving quality documents when required including as a proxy signatory
- Demonstrate commitment to the development, implementation and effectiveness of Sekisui Diagnostics’ Quality Management System per MHRA, FDA, ISO and other regulatory agencies or standards
This job is fully qualified, career-oriented, journey-level position. Typically requires a scientific university degree and a minimum of 10 years of GMP related experience.
The successful candidate should have, but are not limited to:
- In depth knowledge of EU cGMP requirements
- Experience in managing people
- Experience of batch release under supervision of Qualified Person
- Lead auditor training
If this sounds like you, please apply for immediate consideration.
At Sekisui Diagnostics, we help improve patient outcomes by doing what we’ve always done – focusing on innovating and developing highly accurate diagnostics tests, reagents and systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. We will continue to embrace change and challenge new frontiers so that we can create unique, high-quality products and services that will leave our customers truly satisfied. With worldwide state-of-the-art manufacturing facilities and an international sales and distribution network, we are a solid partner for healthcare professionals, distributors, and manufacturers around the world. Our global capabilities allow us to meet the specific needs of our wide range of customers – and customize solutions at both a regional and product level.
Sekisui Diagnostics offers a competitive compensation and benefits package.
Equal Opportunities
As an equal opportunity employer, Sekisui Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, colour, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, other non-job related characteristics or other prohibited grounds specified in applicable country and local laws. It is also Sekisui Diagnostics policy to comply with all applicable country and local laws respecting consideration of unemployment status in making hiring decisions.
Sekisui Diagnostics is pleased to consider all qualified applicants for open roles and encourages candidates to apply online. Only those candidates who are selected for further consideration or interviews will be contacted by a member of the company’s internal recruiting team.