QC Manager

Job Description

Are you a QC Manager looking for your next opportunity If so, an opportunity has just become available to work for a globally established Biotechnology company based in Edinburgh. We have a fantastic opportunity available for a QC Manager to join a world-leading contract manufacturing and development organisation, specialising in the field of cellular therapies, advanced therapeutic medicinal products, and regenerative medicine. This company focuses on proving manufacturingservices for companies developing cell based therapeutic products. They operate a fully licensed GMP manufacturing facility, and they possess a proven track record in the delivery of cell-based products. The QC Manager is available due to growth of the business. This role is well suited to an individual with experience in managing a QC GMP Analytical Biology laboratory or team looking to join an industry leading cell and gene therapy companyat a time of pivotal growth.The QC Manager will be a key member of their QC Management team and will be responsible for co-ordinating the efforts of the QC Analytical team in delivering the testing/monitoring requirements to ensure the release of their cell and gene therapy products.This candidate will ensure that their products are quality controlled to GMP standards, manage in-house and outsourced GMP testing and oversee the collation of all QC documentation necessary for batch release.On offer for the suitable candidate is a competitive salary and benefits package which can be disclosed upon application. Responsibilities of the QC Manager include:

• Management of the QC Analytical function, ensuring that sampling and testing is performed against set specifications in a timely manner and in alignment with approved schedules.
• Direct management of the QC Analytical laboratories to meet operational requirements.
• Authoring and review of change controls, deviations/investigations as well as test methods, specifications and SOPs.
• Supervision of the review of laboratory data and the close out of deviations.
• Review and approval of all QC related documentation within the QMS to ensure work is compliant with the relevant standards/guidelines.
• Scheduling of Analytical testing alongside other departments.
• Ensuring up-to-date training status of all QC Analytical personnel in line with cGMP and provision of specialist training to all required personnel.
• Management of regulatory requirements from MHRA and FDA, ensuring Data Integrity principles are deployed within the team and that issues are escalated in a timely manner
• Continued coaching and development of the QC Analytical team to help them meet both their career and personal development goals ensuring a cohesive, productive and highly motivated team.
• Development and continuous improvement of the awareness of QC staff in the requirements of GMP and best practice for applying GMP within activities.
• Development, collation and reporting of key quality/business related metrics, and use such metrics to drive a culture of continuous improvement and process efficiencies within areas of responsibility.
• Continuous review of QC procedures to ensure their compliance and identification of any appropriate improvements.
• Management of documented procedures for ensuring all raw materials used for Manufacturing are checked and tested against agreed specifications and are only release for use after appropriate inspection procedures.
• Contribution to Management processes by communicating to key management positions the abilities and needs of QC so that business decisions can be made on an informed basis.
• Lead in the recruitment of Quality Control, as required, and ensure that the department is adequately provided with trained, motivated staff who are able to meet all of the requirements.

Qualifications and experience required:

• You will hold a BSc, MSc or PhD in a Life Science or related discipline.
• Significant experience in leading or managing a QC Analytical team or laboratory within the pharmaceutical industry, the biologics industry or stem cell activities.
• A clear understanding of GMP and Quality Control.
• Demonstrable leadership qualities, communication, interpersonal and motivational skills.
• Demonstrable ability to take decisions, to analyse information in a logical manner and to prepare coherent investigative and/or technical reports.