AbbVie Director Quality Assurance m/w/d in Ludwigshafen, Germany

Director Quality Assurance m/w/d

Germany, Rhinland-Palatinate, Ludwigshafen

Quality Assurance

Requisition #1901904

The Quality Assurance Director is responsible for the overall operation of the quality system, ensuring compliance by alldepartments and personnel by development and maintenance oft he company┬┤s products manufactured at AbbVie meet the requirements of end users, of national, international regulatory authorities, pharmaceutical quality standards and of the company.

Responsibilities:

  • Operation oft he quality system andmanage the Quality Assurance Department ensuring compliance by all deaprtmentsand personnel with the requirement of:

  • European Commission Goodmanufacturing pratices and U.S. Food and Drug Administration and others, whereapplicable

  • AbbVie Corporate and GlobalPharmaceutical operations policies

  • Auditing oft he quality system (inconjunction with other management personnel)

  • Ensuring that products manufacturedby AbbVie meet requirements according to registration and manufacturingauthorization

  • Product release as registeredqualified Person (Annex 16) to ensure pharmaceutical compliance of drugproducts for commerical use

  • Liasion with GlobalPharmaceuticalOperations Quality Assurance and other regulatory bodiies e.g. localMOH, FDA,on major issues

  • Notificationofproductrecall/withdrawal from the marketplaceto relevant authoritiesandco-ordination of recall where necessary

  • Assessment oft hepharmaceuticalimpactof analyticaland quality related topics for the drugproducts manufactured on site, incliding disposition of non conforming finishedproduct

  • Management of customer complaintsystem

  • Ensuring internal and externalmanagement is kept informed of system failures on a regular basis

  • Adheres to and supports all EHS& E standards , procedures and policies

  • Working a spart of SeniorManagement to ensur AbbVie meets its customer, quality, services, regulatoryand financial goals

  • Develops strategies and settingpriorities in the implementation of QA activities

  • Reports to the executive board andresponsible for management reviews

  • Ensuring the implementation of newdrug products transfers and responsibilities for pharmaceutical necessarytechnical activities to obatin the approvals for products

  • Gratuated qualification in anatural science like pharmacist with ability to act as a qualified personaccording to Annex 16

  • Minimum 8 years of experience in asimilar role in the healtcare/pharmaceutical industry, including 5 years in amanagement role

  • Experience in personnel management

  • Persuasion and communication skills

  • Analytical thinking as well as a structured,independent and goal-oriented way of working and leadership

  • Very good English language skills

Additional Information

  • Travel: Yes, 10 % of the Time

  • Job Type: Experienced

  • Schedule: Full-time

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