Your opportunity to join a Contract Research Organisation in Chelmsford, Essex as a Quality Assurance Manager is now available. In this senior role you while ensure all UK operations comply with all processes, regulations, legislation, and processes related to Good Laboratory Practice (GLP). Paying up to £70,000 plus a comprehensive benefits package this exciting role offers you to help shape the companies ongoing QA Strategy and direction.
Your duties as Quality Assurance Manager will include
• Management of QA activities across two laboratories in the UK, providing leadership, management, and direction to a team of four.
• Promoting QA and GLP across the business, building a positive culture and supporting new initiatives
• Being hands on in the QA team, Perform laboratory and facility inspections and audit final reports for GLP, study plan and SOP compliance.
• Hosting regulatory inspectors and supporting external audits when required
• Review, management and implement service agreements ensuring Quality Assurance meets requirements
• Ensure all documentation i.e. Quality Policies, Standard Operating Procedures, templates and work instructions are up to date and accurate
• Ensure all QA documentation (i.e. SOP’s) are completed and filed accurately across the business and procedures accurately followed
• Work closely with all departments (i.e. Laboratory, Research and Project team) to ensure QA procedures and systems are followed and new processes implemented.
• Attend Senior Management meetings providing QA input
You must be able to bring strong knowledge of Good Laboratory Practice (GLP) to the role. You will be comfortable working in a hands-on capacity able to carry out internal inspections and audits when required. You will be a confident and supportive manager able to get positive results from your direct reports while installing the importance of GLP and QA across the wider business.
Your knowledge of QA will ideally relate to a pre-clinical (i.e. CRO) environment however commercial experience from across the life sciences will be considered. A degree in a life science subject coupled with a post graduate qualification would be required.
You will be able to bring a calm but tenacious approach the role. Promoting the importance of QA across the business while ensure statistical report and KPI’s are met. This is an exciting and highly important role in the business and your opportunity to join their Senior Management Team.
You may occasionally be required to travel to the other site or clients, but this will be minimal.
The company is paying a salary up to £70,000 plus bonus, private healthcare, life insurance, 25 days holidays.
To apply for this Quality Assurance Manager role contact Kevin McHugh at Senex Recruitmen
- Quality Assurance
- Quality Management
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