CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2’600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.
Our network in Europe and the US offers flexible and specialized solutions across five technology platforms: Peptides, Lipids & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.
To strengthen our Global team in Basel (CH) or Plankstadt (Germany) we are looking as soon as possible for an
Global Quality Excellence Manager 100%
Plankstadt / Frankfurt
Main activities and responsibilities
- Act as a Subject Matter Expert on QMS and Quality Execution Excellence across the CP network e.g. enhancement of systems / processes, quality standards
- Perform internal audits and offer trainings to the sites regarding new compliance topics
- Supervise CP sites on regulatory inspection readiness and inspection management including regulatory responses and action implementation adherence.
- Lead Best Practise and benchmarking activities in the CP network supporting Quality Culture and cross-functional transformation projects
- Drive optimization projects to improve and harmonize compliance workflows in electronic IT applications in tight collaboration with the sites and global IT
- Participate in global Quality projects with focus on continuous improvement and enhancement to the QMS integrating risk management and gap assessment principles
- Moderate Quality ad-hoc boards for Escalations to Management cases rapidly after notification raised by the sites to ensure and support timely actions, effective communication (if needed) and closure of the issue
- Model action plans to continually improve performance in KPIs, with specific focus on RFT and overdue compliance activities to minimize Costs of Poor Quality
- Champion the visualization of regular KPI and QMR reporting in an electronic format to increase transparency and enable the build of organizational efficiencies
- University degree or similar qualification with at least 10 years of working experience in a GxP controlled environment
- In depth-knowledge of FDA- / EU-Guidelines and other relevant quality system requirements
- Skills in risk management and gap assessment principles
- Fluent English, with one additional European language
- Flexibility and willingness to travel (< 20%), Internal auditor trained
- Confident handling in electronic systems, ideally familiarness with Trackwise, LIMS, SAP, eCTD, EDMS
- Excellent interpersonal and communication skills; ability to develop and maintain good working relationships and work productively with others in a team environment
- highly self-motivated with “Can do” mentality and a strong sense of ownership.
What we offer
30 days of vacation
Dynamic and exciting work environment
Positive working atmosphere and open management culture with focus on continuous improvement of processes to stay innovative
Subsidy for fitness studio
Do you require more information?
In case of questions to your application, the position or something else I am very happy to support you.