QA Manager Biologics (m/f)

Einsatzort: Ludwigshafen

QA Manager Biologics (m/f)

QA Manager Biologics (m/f)

Overall objective:

 

Proactive Risk- and Compliance- Management regarding Biologics Products

 

Tasks and Responsibilities:

  • Proactive compliance, implementation management of upcoming new legislation and AbbVie internal procedures.
  • Biologics Products Risk Management, coordinate and implement e.g. RCSs and FMEAs, assure to stay within given timelines.
  • Biologics QA/QC improvement, gap analysis, plan approval and supervision of mitigation actions. Drive changes.
  • Independent reviewer for change plans.
  • LU MAI and AAI Pen supply chain packaging projects.
  • LU Pen: optimization projects.
  • Quality Manager acc. to SMF.
  • Projects concerning New Biologics Entities (NBEs) and Humira.
  • Pre-Market Reviews and Post Market Reviews of Biologics Products.
  • Assure internal and external legislation or guidelines become implemented in time, assure inspection readiness, use post-audit preparation for system improvements
  • Profile:
  • Natural scientist or engineer, e.g. Pharmacist, Biologics Engineer.
  • Analytical thinking and able to find practical solutions, MindSetting to make things happen with a global approach.
  • Total combined years: 5+ in QA, Operations or Technical Support in a Pharmaceutical setting including quality assurance and/or quality system oversight.
  • Comprehensive understanding of pharmaceutical QA, QC and Q-Systems.
  • Total combined years: 5+ in QA, Operations or Technical Support in a Pharmaceutical setting including quality assurance and/or quality system oversight.
  • Strong background in GMP, experience with Regulatory Inspections.
    Strong team player and facilitator, strong communication skills.

  • Experience in project management including troubleshooting skills
  • Able to negotiate in English, fluent spoken and in writing

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.