Global Senior Director Quality & Regulatory Affairs - Plastic Packaging
- Klaus-Bungert-Straße, Düsseldorf, Germany
Gerresheimer is a leading global partner to the pharma and healthcare industry. Since its foundation in Germany in 1864, the publicly traded company now operates worldwide with 10,000 employees and generates revenue of €1,4 billion. Gerresheimer’s Plastic Packaging product portfolio consists of a widely varied spectrum of pharmaceutical plastic packaging within solid, liquid and ophthalmic applications, parenteral vials and plastic bottles for personal care.
Our Business Unit Primary Packaging Plastics has manufacturing facilities in Asia, Europe and North-and South America.
For our international Business Unit Plastic Packaging we are looking for an outstanding personality to support our ambitious global growth plans.
In your function, you are responsible for the implementation of our quality vision, strategy and quality culture. In addition, you are the overall responsible for quality development, market expectations and their customer requirements by setting up new operations globally.
- Ensure standardization within the Business Unit and continuous development of the quality management system
- Overall responsible for Regulatory Affairs and thus ensure that the Business Unit knows all relevant regulatory requirements for the specific region
- System owner of the global library and overall responsible for standard product database and customer handbooks.
- Maintain a close relationship with our customers by evaluating and negotiating customer agreements and implementing them
- Perform customer quality reviews and participate in all recalls – external and internal
- Ensure sufficient reporting structure to create a constant overview of our quality position
- Overall coordination of Gerresheimer Management System (GMS) with focus on Quality Management and ensuring that each plant is progressing in implementation of GMS
- Member of the Gerresheimer Quality Council and representative of the business unit
- Implementation of agreed strategies, policies, actions, minimum requirements etc. from the Gerresheimer Quality Council
- Supervision of Quality Managers and support of management teams in quality and environmental issues
- Participate in setting-up and integrating new operations in the Plastic Packaging area
- Maintain a quality forum for the quality management teams to ensure exchange of best practice, knowledge sharing and experience
- Good theoretical background (academic) combined with minimum 10 years working within Quality and minimum 5 years as Quality manager in a mid-size companies, preferably supplier to the pharma industry
- Have been working with customers connected with quality and with regulatory issues – preferable FDA and EMEA
- Very strong in quality and regulatory area within Pharma and / or devices
- Knowledge to all basic standards - ISO 9001, 14001 and 15378 and/or 13845
- Knowledge to FDA / EMEA requirements
- Used to work with customers and interact with other professionals within the area of quality and regulatory
- Work location flexible within EU - preferably Germany or Denmark
- Travel frequency around 50%