Senior QA Manager

Hobson Prior are looking for a Senior QA Manager to join an excellent biotechnology organisation on a permanent basis located in Livingston. Our Client is focused on evolving and commercialising inoculations for infectious illnesses.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this role, you will Ensure the Quality Assurance department’s resources are used effectively, efficiently, and accountable by managing the organisational structures, policies, procedures, and processes.
• Oversee all internal site operations required for manufacturing, testing, and releasing products in accordance with all facilities, systems, processes, and best practices.
• Work with senior quality assurance management to ensure compliance with EU/FDA Good Manufacturing Practices and Good Distribution Practices for pharmaceutical testing and manufacturing.
• Maintain appropriate and timely escalation and resolution of deviations, changes, and CAPAs in the area of responsibility pertaining to materials, facilities, processes, or procedures.
• Support compliant business operations by directing and overseeing the self-inspection and external audit systems on site.
• Assure management has access to key quality metrics for the Audit programs, to drive continuous improvement and compliance with current regulations, quality requirements, and the business requirements.
• Ensure site readiness, hosting, timely response, and close-out of audits / regulatory inspections.
• Ensuring that key investigations are delivered in compliance with QA standards.
• Ensure documentation reviews are carried out in accordance with relevant Standard Operating Procedures.
• Maintain batch release procedures in accordance with relevant procedures, including issuing certificates of conformity for bulk drugs.
• Ensure that documents are managed and performance is measured on time.
• As required, report quality issues to the Quality Review Board (QRB) and local QA governance bodies according to the QRB’s requirements.
• Inform the Site Director, Director of Quality Operations, and Qualified Person(s) of any material breach of quality or regulatory compliance.
• Contribute to the development of business-effective, compliant systems to support operations and processes on site.
• Provide support to site QPs in delivering batch documents and systems that meet market release requirements.
• Under the direction of the Director of Quality Operations, perform any other reasonable duties as requested by the Director of Quality Operations.
• As needed, shift work and out-of-hours work.

Key Skills:

• Strong deadline management and prioritisation skills

Requirements:

• Education at the college or university level or equivalent work experience is required.
• An operational management background demonstrating compliance with GMP/GDPR standards and regulatory requirements.
• Knowledge of EU/FDA and cGMP/GDP requirements for the manufacture and testing of biological products.
• An understanding of how to plan, coordinate, and implement quality improvements.
• An understanding of the pharmaceutical industry and working knowledge of it.
• Worked with operational excellence improvement tools for a number of years.
• Delivering quality metrics with experience as a leader.

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.