When you join us, you would be surrounded by diverse, hardworking, quality minded colleagues. In leading effective QMS processes and driving regulatory compliance, you will be assuring product quality and patient safety.

The successful applicant in this role will undertake various tasks in the site's Quality Management System (QMS). They will ensure product safety, efficacy, and quality.

Responsibilities and Duties

We seek an individual who is proactive, innovative, and quality-minded. They should have up-to-date knowledge and a passion for improving the QMS and ensuring compliance with cGMP regulations.

Every day could be different, leading and supporting a range of activities including risk management, internal & external audits, training, change control, deviations and CAPA, supplier assurance, document lifecycle, and metrics reporting. As process owner for one or more of these processes we need someone to drive the ownership and accountability for process compliance!

• Lead internal audits, supporting site inspection readiness
• Collaborating sitewide to ensure key objectives are efficiently achieved.
• Sharing knowledge, and a quality passion, whilst training others.
• Evaluating risk throughout processes
• Write, review, and approve a variety of documents, including procedures, deviations, risk assessments and change controls.
• Efficient use of all available electronic tools (e.g. Trackwise, eDMS, SFLMS) to support site success.
• Extract, analyse, and interpret QMS data to support management reporting, proposing innovative solutions to any trends identified.

Do you have a proactive approach to problem solving, challenging assignments and working to critical timelines?

You will support and mentor the team, stepping in for the Quality Compliance Manager as needed to ensure smooth compliance management.

Support the organisation by undertaking any other quality-related tasks

Embody Thermo Fisher's 4i values in all that you do.

Be motivated to improve and simplify processes, and actively participate in our continuous improvement program (PPI).

Ensure compliance with environment, health and safety rules, timely reporting of any accidents & near misses.

This role offers exposure to various quality functions, providing diverse experiences. With self-motivation and passion, candidates can enjoy limitless growth opportunities. As a global leader, we offer a wide range of possibilities.

Education & Skills

• Relevant science-based degree such as Chemistry, Biology, or Pharmacy
• Build over years extensive relevant pharmaceutical/biotech experience in a cGMP regulated environment (e.g. FDA, EU GMP, JP)
• Qualified Lead auditor
• Able to communicate effectively to all levels of the business