Hannah Milward at CK Science is currently recruiting for a Temporary Site QA Lead to join a pharmaceutical and biotechnology company at their site in the West Midlands
A Site Quality Leader is responsible for ensuring quality and regulatory compliance of the facility, while driving process effectiveness and efficiency. The Site Quality Leader represents the company to external agencies and champions the evolution of the quality culture for the site.
Key responsibilities of this Site Quality Leader role will include:
- Directing the Site Quality Management System, fully integrated into the Global Quality Management System, including cross-functional and site-specific processes. The role is responsible for facility compliance covering voluntary, regulatory and company quality requirements and will champion quality initiatives at all levels of the organisation.
- Maintaining and improving all aspects of Site Quality Planning.
- Overseeing all Quality-related communications and training requirements for all site employees
- Establishing positive relationships with outside agencies
- Hosting Quality System audits and inspections
- Overseeing the Corrective Action / Preventive Action activities and Complaint Handling Programs, and in some cases, Quality Engineering
- Report on Quality System effectiveness and requirements to management team as required including preparing and executing facility Quality Management Reviews
- Driving the definition of site quality objectives, metrics, reporting and operating mechanisms
- Participating in selected global initiatives to share best practices and leverage quality synergies
- Supporting local R&D programs and quality issue resolution
- Acting as Management Representative for Quality at the Site
- Operates a Local Inspection program and manages f/up activities to close NCs.
To be considered for this Site QA Lead role you will have:
- A Bachelor’s degree or equivalent in Engineering, Medical Device Technology or Scientific Field
- You will have an understanding of product development, manufacturing, quality control and servicing in the medical equipment or pharmaceutical industry.
- You will also have hands-on experience with FDA, QSR, ISO, MDD and/or other international quality systems requirements.
For more information or to apply for this Site QA Lead role please contact Hannah Milward on 0114 283 9956 or email firstname.lastname@example.org. Please quote reference SH24376 in all correspondence.