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 between Heidelberg and Mannheim (Germany) we are looking as soon as possible for a
Basel (CH), Plankstadt
Main activities and responsibilities
Reviewing the effectiveness of the sites‘ Quality Systems and inspection readiness though the annual site corporate audits, Quality Review of KPIs and through routine contact with the sites on Qualitymatters especially regarding sterile operations / aseptic processing
Ensuring appropriate communication with the site and Chief Quality and Compliance Officer through site visits or appropriate alternative contacts (example: Teleconference or web meeting)
Providing a consolidated monthly report on sites‘ Quality activities and key performance indicators
Ensuring that the sites‘ Quality units are adequately trained in the respective Quality System modules and Regulatory requirements and providing / organizing appropriate training on site if needed
Integrating risk management and gap assessment principles into the CordenPharma Quality system
Performing Quality ad-hoc boards rapid quality notification raised by the sites to ensure and support timely actions, escalation (if needed) and closure of the issue raised
Keeping the sites informed on regulatory and CordenPharma expectations concerning Quality and Compliance
Organization of Quality networks to assist in sharing of information, identification of best practices and actions on continuous improvement
Promoting aseptic processing performance and innovation initiatives
Leading specific Quality topics, as agreed with the Chief Quality and Compliance Officer
Development of the sites‘ annual Quality program, ensuring full alignment with the Corporate Quality and Compliance Officer. Roadmap priorities / actions and with the site specific objectives
PhD degree qualification in Pharmacy, Microbiology or relevant Life Sciences
The role requires minimum 15 years of expertise in Good Manufacturing Practices
Microbiological and sterile operations experience highly appreciated (long term background in aseptic drug product / drug substance manufacturing)
Broad knowledge in GMP Quality requirements
Profound experience in managing FDA and GMP-inspections
Several years‘ operational experience in Quality leadership, preferably as a Site Quality Head
Excellent communication (both written and oral) skills
Good leadership and influencing skills to operate in a cross-functional and international environment
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
If you enjoy working in a team and are interested in a varied area of responsibility, if you think and act beyond your own areaof responsibility, then you should join our team.
Do you require more information?
In case of questions to your application, the position or something else I am very happy to support you.
Global HR Business Partner
Corden Pharma GmbH
Otto-Hahn-Strasse | 68723 Plankstadt
Corden Pharma International GmbH https://files.relaxx.center/kcenter-google-postings/kc-16016/logo_google.png
Plankstadt 68723 Otto-Hahn-Straße