Manager Product Complaints QA (m/f)

Einsatzort: Ludwigshafen

Manager Product Complaints QA (m/f)

Manager Product Complaints QA (m/f)

Overall objective:

  • Manage international complaint handling (e.g. biologics, Duodopa, or other marketed products)
  • Responsibilities of Deputy Head of Quality for finished goods
  • Making difficult decisions and management of critical situation with significant impact to products.
  • Ensure compliant and timely product complaint documentation, investigations and identification of potential adverse events and potentially reportable events as well as releases in order to assure patient supply.

Main Responsibilities:

  • Maintain oversight and harmonize international complaint handling. Ensure global alignment of complaint handling. Assure complaint records meet global requirements
  • Coordinate complaint handling with affiliates, especially in regards of agency requests on complaints. Identification of potentially reportable events and notification to appropriate functional groups and management
  • If qualified as QP: Perform batch releases as QP for products released in Ludwigshafen according to § 19 German Drug Act AMG
  • Planning of resources of GPWA team, develop, lead and coach direct reports.
  • Interface with Third Party Manufacturers, health care professionals, general public, internal customers, AbbVie functional areas and regulatory agencies.
  • Drive continuous process improvement projects.
  • Potential oversight of management of a project team or participation on a project team involving process improvements, new product launches, issue resolutions, etc. 
  • Train pharmaceutical interns

Your profile:

 

  • Master Degree in sciences; ideally a PhD in natural sciences; Licensed Pharmacist preferred
  • Preferred qalification as Qualified Person according to EU GMP respectively Sachkundige Person according to German Drug Law
  • Comprehensive understanding of pharmaceutical QA, QC and manufacturing for finished products.
  • Total combined years: 2+ in QA, Operations or Technical Support in a Pharmaceutical setting including quality assurance and/or quality system oversight.
  • Project management and troubleshooting skills.
  • Ability to communicate, understand, and direct individuals in highly specialized technical fields.
  • Knowledge of U.S. and international regulations for quality systems and compliance.
  • Experience in handling inspections and direct interaction with regulatory authorities, e.g. FDA and EMA.
  • Leadership of other technical professionals and experience in leading cross-functional teams with results-orientation.

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.

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