Job Description
Senior Manager Quality Systems (f/m/d) - global QMS Business Process Owner
for the site Starnberg (Percha), Germany
Would you like to make a valuable contribution to the health of patients? And do something really meaningful on your own responsibility? Then we look forward to hearing from you! Excellence beyond manufacturing - that's what we stand for as Aenova, one of the world's leading contract manufacturers and developers for the pharmaceutical industry with 4,000 employees at 15 sites. Our site in Starnberg is the headquarters of the Aenova Group.
- Lead and manage a team of Quality Managers responsible for their business process area (documentation, training, eQMS…) and work in close collaboration with colleagues in charge of CSV, supplier qualification, audits and inspection, regulatory surveillance
- Support the digitalization deployment of the Quality overall strategy and roadmap aligned with business and site operations objectives
- Define the Aenova standard Quality processes and being accountable of sites/departments alignment on the standard processes as deployed within the gQMS
- Provide technical and regulatory guidance, establish training plans, perform coaching on the gQMS and ensure that gQMS is deployed at the manufacturing sites, promote usage of the systems
- Manage with the relevant stakeholders the creation and revision of the global documents including Quality policies, global SOPs, and guidelines etc.
- Actively support the holistic Aenova Quality culture concept enabling a constructive and sustainable “One Quality” mindset, fostering an open and collaborative environment for continuous Quality improvement within the organization
- Minimum 10 years professional experience in the Quality Unit of a pharmaceutical, biotech or medical device company, in a senior manager role (e.g. Department Head)
- Advanced Degree (e.g. PhD) in Pharmacy, Chemistry, Biology or related science e.g. IT, engineer
- Strong team player, demonstrated knowledge, implementation and execution of Quality System Management
- Ability to conceptualize, analyze, plan and manage in a dynamic and fast-paced environment
- Ability to work in a matrix organization and capacity to negotiate, having excellent leadership and communication skills to guide and lead international teams, providing direction to meet business objectives
- Solid background in MS-Office suite and other IS tools
- Outstanding language skills, both written and verbally, any other language is a plus