An industry leading pharmaceuticals products group with a network of global locations is looking to hire a Senior Quality Assurance Manager to lead quality operations for their newly acquired site to the South of Berlin.
This is a site leadership position managing German quality operations and future European expansion reporting to the European Quality Director. The primary focus will be aligning QA processes to the group by implementing a new quality management structure, developing your team, and standardising the QMS to match global quality operations.
The business are a contract manufacturer and service provider for the worlds leading pharmaceutical and biotech groups. This is an exciting role that reports to global where you will grow out quality operations in line with the company's planned continued expansion in Germany.
As Senior Quality Assurance Manager you would be responsible for:
- Site lead for Berlin quality operations for both clinical and commercial
- Introducing and implementing the quality processes for the site and aligning to group level
- Transitioning the acquired site to corporate quality standards
- Maintain compliance with GMP and customer expectations
- Management, development and growth of the activities of the quality operations team
- Setting the strategy for and direction of the performance goals for quality
- Support continuous improvement projects including new product introductions into the site.
- Identify opportunities for improving internal processes and or procedures
- Promoting and building a training culture which is adaptable to account for the ongoing build of the organisation in Germany
- Managing the Quality system programs used - audits, training, SOPS, documentation, change control, complaints, investigations and CAPAs
- Management of the licenses held in Germany and the associated variations and new license applications.
Key experience required:
- Demonstrable experience of manufacturing or production activities within the pharmaceutical industry.
- Experience of managing a team in support of quality critical activities
- Demonstrable experience within Quality systems and QMS management
- Excellent working knowledge of cGMP
- Qualified to Degree level in a science, engineering or similar field
- Good interpersonal skills, ability to interact with cross-functional teams and multiple stakeholders
A salary of €95,000 to €110,000 is on offer for the Senior Quality Assurance Manager with the ability to go higher to attract a candidate who could also act as a Qualified Person.
This position is a key hire and the intention is to begin interviewing from mid-September so please apply as soon as possible to be considered. You can also contact James Ivall at Goodman Masson should you have any questions or want to discuss the role in more detail prior to applying.