A leading pharmaceutical company near Munich are hiring a Quality Director at their manufacturing site. The position is responsible for managing the site's entire Quality unit of 90+ personnel.
The Quality Director is responsible for setting the strategic direction, properly staffing and maintaining the Quality Management Systems (QMS) to assure the site is always compliant. Alongside this, they will provide project guidance and support customers to resolve quality complaints.
Responsibilities:
- Strategic overview of the site's Quality department (90+ personnel) including Site Quality Plan, Quality Unit objectives and related procedures.
- Maintain and enhance an effective Quality Management System (QMS)
- Interface with all other departments to ensure compliance with cGLP/cGMP.
- Monitor site compliance to FDA, EU and all other applicable requirements.
- Release of finished goods according to ยง19 AMG.
- Primary contact for both regulatory bodies and customers
Requirements:
- 10+ year's experience in Pharmaceuticals with a focus on Quality Management
- Demonstrated leadership ability of controlling large Quality units
- Fluent in English, German B2 level minimum
- Knowledge of cGMP, GLP, ICH, and EP, USP, BP regulations or guidelines
- Expert knowledge as a Qualified Person preferable
- Excellent communication and organisational skills
Re-numeration:
- โฌ120,000 - 150,000 gross annual base salary
- 10 - 15% incentive bonus
- Secondary benefits; Pension, company car, etc.
