A global pharmaceuticals business based in South East England are searching for a Senior Quality Assurance Manager and Qualified Person to lead quality operations across European and US sites. Reporting into the Senior Director in the US, the role will hold full QA responsibility for onsite and CMO manufacturing operations globally.
The key aim of the Senior Quality Assurance Manager will be to help shape the strategic direction of the business by harmonising quality processes, driving global improvement projects, and building a robust quality infrastructure for future business objectives.
A great candidate for this role will have previously helped shape quality direction, managed a team and delivered key quality objectives either across a business or large department. You will also need to be eligible to be registered as a Qualified Person on the manufacturing license.
Key responsibilities as Senior Quality Assurance Manager:
- Manage multi-site Quality Management System and continually improve global processes.
- Develop and execute quality plans and project timelines to meet company goals
- Ensure all quality compliance requirements are fulfilled for the manufacture and supply of products for respective country requirements
- Lead strategic projects from a quality perspective
- Support as auditor for supplier quality and internal audits
- Senior business partnering with corporate groups to drive quality programs
- Responsible for quality department budget/cost centre
- Deputize for the Senior Quality Director when required
- Management of the Qualified Person batch release process
- Leadership of a QA team and key QA processes
- Thorough knowledge of cGMPs and cGDPs for medicinal products
- Direct experience with regulatory inspections
- Ability to manage and drive change
- Ability to matrix manage projects with multiple functional groups
- Must be eligible to be named as a QP on the company license
The role of Senior Quality Assurance Manager is paying £95,000-110,000 with the ability to go higher for an individual with very relevant experience.
This is a great opportunity to shape the growth and expansion of a leading pharmaceuticals manufacturing business as a senior manager within global Quality Assurance operations. It is a business-critical hire for the group so interviews will be taking place in February.
Please apply by this advert or contact James Ivall at Goodman Masson on +44 207 324 0538 should you have any questions prior to applying.
I look forward to hearing from you.