Careers

Corporate Head of Quality & Regulatory Affairs (m/f/d)

CordenPharma International (CPI) Plankstadt
Plankstadt, DE

CordenPharma International

Plankstadt, DE

CordenPharma International (CPI)

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 Quality team we are looking as soon as possible for a

Corporate Head of Quality & Regulatory Affairs (m/f/d)

which will be located in Basel (CH), Frankfurt (Germany) or Plankstadt (Germany).

Main activities and responsibilities:

Main scope of the job role is to lead the global corporate compliance function. This consists of Quality Audit, Quality Systems, Regulatory Affairs, GxP Validation. The role leads a team to ensure a compliant Quality System throughout all CP-Sites and to improve the individual Quality and Compliance workflows according to expectations of relevant authorities, customers.

The Corporate Head of Quality & Regulatory Affairs (m/f/d) is the owner of the following tasks:

  • >>  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 Quality matters 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

Skills:

  • >>  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:

  • >>  Dynamic, fast-paced work environment
  • >>  Positive working atmosphere and open leadership culture focusing on continually improving the processes to remain innovative
  • >>  Potential for career growth on an expanding team within an organization dedicated to improve the quality of living of people
  • >>  Possibility to work remotely for a certain amount of time

If you enjoy working in a team and are interested in a varied area of responsibility, if you think and act beyond your own area of responsibility, then you should join our team. Please send your detailed application documents with salary expectations and earliest starting date to:

CORDEN PHARMA INTERNATIONAL GmbH
Human Resources
Karlheinz Kelsch
Otto-Hahn-Straße
68723 Plankstadt
Phone: 0 62 02/99-56091
E-Mail: [email protected]

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