Quality Compliance Manager

Date Posted: 5/14/2018 Reference: VAC-1004828 Salary: £45000 Location: CAMBRIDGE Job type: Permanent Sector: Science | Speciality: Pharmaceuticals Contact: Emily Wilcock
Description

The Client

My client provides proprietary technologies and complementary services to organisations involved in the development of biopharmaceutical products.

Working with companies and academic groups all over the world, including most of the top 20 biopharmaceutical companies, my client supports the development and manufacture of better treatments for patients

The Role

To lead and manage the Company’s Quality Management system and ensure that the Company is compliant with legislative and regulatory requirements in respect of scientific work undertaken.

To develop and maintain a Quality Management System (QMS) to ensure that the company complies with legislative and regulatory requirements and best practices, particularly with respect to the use, storage and disposal of: -

• Human tissues
• Radioactive materials
• Genetically modified organisms (GMO)
• Other hazardous materials, including toxins and cytotoxic compounds

Responsibilities

• To oversee the application and/or maintenance of the Human Tissue Act (HTA) licence, Research Ethics Committee (REC) approvals (for the use of human tissues) and notifications under the GMO and radioactive waste regulations
• To monitor the legislation and regulations applicable to the company’s scientific activities and implement any changes required to ensure that the company remains in compliance
• To develop and maintain a Company database of COSHH forms and Risk Assessments and ensure staff are aware and adhering to them
• To develop and maintain a database of Material Safety Data Sheets (MSDS) and ensure that a MSDS is available for all materials that are being used
• To develop, implement and manage the Company’s scientific document retention policy
• To develop a plan for implementing ISO9000 compliance in Cell Line Development
• To develop and implement a plan to allow GMP compliant sub-contracting within the Group companies including any GMP analytical services carried out in Cambridge
• To develop and maintain the UK Company’s QMS and where appropriate ensure this is aligned with US groups
• To lead the development and implementation of new SOPs and ongoing review, revision and replacement of SOPs
• To identify and develop ways to improve quality across the Company and ensure best practice is adopted throughout the organisation
• To conduct regular internal audits for compliance with the legislation, regulations and the QMS and ensure that corrective and preventative actions (CAPA) are implemented and provide a written report of such audits and the CAPA to the Board Audit & Compliance Committee
• To ensure that external audits under scope of this role, including by regulatory agencies, are prepared for
• To undertake any other duties relevant to the position and level
• To effectively manage one or more teams and, through the performance management system, provide guidance and support associated with both their technical and personal development
• To foster relationships with key internal and external stakeholders and partners to support proactive compliance with legislation and regulations and the Company’s QMS
• To take the lead in providing training to staff to ensure that they are aware of the legislation, regulations and best practices that affect their work and what they need to do to comply with them
• To be a member of the HTA Governance Committee

The Candidate

• Experience of working in a regulated environment
• Familiarity with Quality Systems including EU GMP
• Experience of developing and/or maintaining a QMS and of conducting audits
• Excellent interpersonal skills, including tact and the ability to foster good relationships
• Planning and Organisation
• Able to effectively plan and organise own work load and that of small teams of reports
• Communication
• Excellent communication skills, including the ability to write clearly and unambiguously to Regulatory standard
• Focused to achieve results
• Critical and intelligent attention to detail and high standard of accuracy in own work
• Desirable Skills & Qualifications
• A higher degree within the Life Sciences
• Understanding of scientific research
• Working experience of the Human Tissue Act
• Experience of working within a GMP regulated environment

Salary is negotiable on experience