QC Director (GMP)

Hobson Prior are currently in search for a QC Director (GMP) to join a leading biotech organisation on a permanent basis in Stevenage. Our client concentrates on developing pioneering gene therapies to enable people living with chronic diseases live a better life.

Job Responsibilities:

• Line management, appraisal and development of GMP QC team members.
• Working with Analytical development, ensure creation and delivery of optimal QC strategies for clinical Programmes, covering product/process development, batch release, stability and provision of data for regulatory submissions.
• Accountable to support and manage outsourced programmes of work, providing scientific scrutiny and interpretation, ensuring commercially viable outcomes.
• Development of laboratory capacity/facilities and expertise in GMP QC labs ensuring best practice and technical excellence.
• Oversee QC laboratory operations compliance with GMP standards.
• Develop specifications and testing protocols commensurate with stage of product development.
• Oversee technology transfer of GMP QC tests between labs.
• Set implement of strategies for the continued development of QC testing capability including building and gaining approval for the GMP QC function business plan.
• Manage analytical methods transfer, development and validation at partner contract research organisations, ensuring compliance with relevant specifications, standards and processes, ensuring data integrity.
• Delegate duties and responsibility to Senior GMP QC staff.
• Support Quality Assurance auditing of service providers from a Technical perspective.
• Provision of training, coaching and mentoring of junior scientists and contribution to an ethos of excellence and high achievement.

Key Skills:

• A proven track record of cross function working.
• Demonstrated ability to work well in internal and external teams.

Requirements:

• BSc in Analytical sciences, Biological science or related discipline.
• You will have a minimum of 12 years' experience of Quality Control in the pharmaceutical industry with experience of biopharm/vaccines or cell/gene therapy products
• Relevant biopharmaceutical industry experience and professional judgement required to plan and accomplish development goals in an organised fashion.
• Practical experience of analytical validation and technology transfer.
• Practical experience of analytical techniques such as qPCR, DNA Sequencing, Immunoassays, Electrophoresis, Cell Based Assays.
• Extensive knowledge of GMP and Regulatory requirements.
• Prior experience in Quality Management Systems.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.