Treffen Sie AbbVie auf der T5 JobMesse

Head of Product QA (f/m)

Einsatzort: Ludwigshafen

Head of Product QA (f/m)

Head of Product QA (f/m)

The Head of QA Compliance/Product QA is responsible to ensure that all products are manufactured and tested in compliance requirements of the marketing authorisation and with Good Manufacturing Practices

The Head of QA Compliance / Product QA represent the site in place of the QA Director and the site Director in all relationship with regulatory authorities, both local and from markets all over the world, liaising for the site in GMP matters and ensuring site manufacturing authorisation/licence  is maintained  and renewed.

 

Major Responsibilities:

  • Batch Record review and batch release - Ensuring product manufacturing and testing process is reviewed,  all exceptions which may result in product non conformities or quality issues and all changes having quality or regulatory impact are appropriately evaluated/managed to enable batch release. Ensure batch release is executed in compliance with regulation and in a timely manner to satisfy business needs.
  • QP Duties - Ensure all QP duties are fulfilled according to Annex 16 EU GMP regulation requirements by managing a team of QP.
  • Product and processes performances – Ensuring product and processes performances are appropriately monitored through, track and treding process, trends evaluation, product quality review, stability review and appropriate decisions are taken by Site Heads (QA and Site Director) or by global CMC teams on changes and/or  improvements needed. 
  • Regulatory Compliance/NPI - Leading New Product Introduction. Ensuring compliance to filing and compendial requirements. 
  • Relationship with authorities and global AbbVie functions. Managing relationship/contacts with authorities in relationship to product quality and to maintain site authorization. Representing the site in place of QA Director and Site Director. Representing the site in global compliance initiatives, bringing added value from site in definition of global Quality System.
  • People Management – Leading a department of over 10/15 people to deliver major responsibilities of the function, ensuring performance reviews, talent management, development and training.
  • Compliance processes efficiency – Ensuring compliance processes are continuously measured and improved and resources usage is optimized, through application of business excellence and innovation concepts, supporting Site financial needs on overhead control.  Anticipating constrains and remediation.
  • Ensuring departmental compliance to all relevant Quality/H.R./EHS&E policies, procedures and guideline
  • Degree in Chemistry / Pharmaceutical Chemistry /Pharmacy and Certification to be a Qualified Person
  • Minimum 10 years of experience in Pharmaceutical industry, possibly on Drug Product (API as alternative may be acceptable, both API and DP would be strong plus).
  • Demonstrated experience in operations, Quality Assurance (at least 5 years), NPI/pharmaceutical develoment
  • Excellent knowledge of GMP regulation (EU/FDA), agencies expectations. Active participation to GMP working groups is preferred. Direct management of inspection is preferred
  • Good understanding of operations business (from supply to final product delivery)
  • Strong leadership skills and significant experience as line manager
  • Articulating what is wrong, why, and how to resolve it across the cross-functional team
  • Passion for Performance and drive for innovation
  • High degree of self-motivation/proactivity and efficient results-oriented way of working
  • Excellent communication and presentation skills

We are looking forward to your application. Please provide information about your salary expectations and possible start date in your motivation letter.

An equal opportunity employer. AbbVie welcomes and encourages diversity in our workforce.

 

Learn more about AbbVie Deutschland at www.abbvie.de. Visit www.abbvie-care.de for more information about the therapeutic areas in which we’re active.

AbbVie (NYSE:ABBV) ist ein globales, forschendes BioPharma-Unternehmen, das sich der Entwicklung innovativer Therapien für einige der komplexesten und schwerwiegendsten Erkrankungen der Welt verschrieben hat. Mission des Unternehmens ist es, mit seiner Expertise, seinen engagierten Mitarbeitern und seinem Innovationsanspruch die Behandlungsmöglichkeiten in vier Therapiegebieten deutlich zu verbessern: Immunologie, Onkologie, Virologie und Neurowissenschaften. In mehr als 75 Ländern arbeiten AbbVie-Mitarbeiter jeden Tag daran, die Gesundheitsversorgung für Menschen auf der ganzen Welt voranzutreiben. In Deutschland ist AbbVie an seinem Hauptsitz in Wiesbaden und seinem Forschungs- und Produktionsstandort in Ludwigshafen vertreten. Insgesamt beschäftigt AbbVie Deutschland rund 2.600 Mitarbeiter. Mit rund 29.000 Mitarbeitern weltweit vertreibt AbbVie Medikamente in mehr als 170 Länder.

Ähnliche Jobangebote