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Associate Director, Quality Assurance Specialist

vor 2 Monaten


Munich, Bayern, Deutschland Organon Vollzeit
About the Role

Organon is seeking a highly skilled Associate Director, Quality Assurance to join our team in ensuring compliance with external and internal requirements pertaining to wholesaling and distribution activities.

This role will serve as the Quality Responsible Person (QRP) for the Wholesale Distribution Authorization (WDA) for our company in Germany and will also be responsible for the Quality Management System (QMS) for the Austrian market.

The successful candidate will be responsible for local quality activities and will have the primary objective of securing compliance with regards to quality, safety, and Good Distribution Practices.

This role will involve interacting with a broad spectrum of internal and external stakeholders, including internal management functions and local Health Authorities.

The responsibilities of the QRP include the authority to act and take decisions to fulfill agency requirements and to safeguard patient health.

Key Responsibilities
  • Ensure compliance with applicable local and EU regulations around Good Distribution Practice of medicinal products for human use.
  • Be the primary point of contact for local Health Authorities with regards to quality matters.
  • Ensure the fulfillment of applicable regulations around Medical Devices.
  • Responsibility for the creation and maintenance of Quality Management System procedures pertaining to the Quality (GDP) area.
  • Ensure the handling of Product Quality Complaints (PQCs).
  • Ensure the handling of, and be overall responsible for, local quality tasks and responsibilities related to e.g. deviations, CAPAs, recalls, self-inspections, and audits.
  • Ensure the training of personnel and maintenance of local quality training programs.
  • Ensure internal reporting and agency notifications of stock-outs.
  • Local management of administrative holds.
  • Management of product samples and repackaging/re-stickering activities as needed.
  • Review and approve Quality Agreements, e.g. with distributors and other contracted parties.
  • Ensure the performance of Management Quality Reviews and establishment of Quality Metrics.
  • Host agency inspections.
  • Local GDP activities will be managed under your supervision and guidance.
Requirements
  • Master of Science in Pharmacy or other life science Master's degree (such as biology, medicine, chemistry).
  • Solid experience from a quality assurance position in the pharmaceutical industry.
  • Previous experience of holding a position as Quality Responsible Person or deputy.
  • Experience with people management is preferred.
  • Solid experience in interacting with Health Authorities.
  • Strong leadership skills and problem-solving skills.
  • Excellent communication and prioritization skills.
  • Fluency in German and English.
About Organon

Organon is a global healthcare company focused on making a world of difference for women, their families, and the communities they care for.

We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars, and touching lives with a diverse and trusted portfolio of health solutions.

Our Vision is clear: A better and healthier every day for every woman.

As an equal opportunity employer, we welcome applications from candidates with a diverse background.