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AbbVie Complaint Handling Manager m/f/d in Ludwigshafen, Germany

Complaint Handling Manager m/f/d

Germany, Rhinland-Palatinate, Ludwigshafen

New

Quality Assurance

Requisition #2002483

We are looking for our site in Ludwigshafen/Rhine for a highly motivated

Complaint Handling Manager/w/d

The Complaint Handling Manager is responsible for the organization, administration, and supervision of 6- 10 product complaint analysts. The complaint analyst role consists of managing the complaint process from beginning to end which includes requesting return samples for lab evaluation, assignment of tasks for various required investigations, and summarizing/closing the complaint records for Abbvie products. Further he/she is responsible for the complete oversight of the day to day operations, including people management/development, ensuring regulations are met, good documentation practices and provides oversight for complaint systems and procedures

The objective of this function is to ensure compliance with regulatory and corporate requirements, assure product quality and develop and maintain operable quality systems that are effective and efficient. The Complaint Handling Manager manages the daily activities of a department including Document updates, , Complaint Handling activities, Audit Support, Training, and CAPA.

Responsibilities:

  • Management and oversight of Complaint Analysts to include: hiring, setting performance expectations, providing performance feedback, development of staff and handling of personnel issues.

  • Daily operations and functions of the complaint group

  • Evaluation/approval of complaint records based upon knowledge and experience, which determines the final outcome of the complaint.

  • Independent planning and coordination of investigations to ensure timely execution of complaints according to PMQA requirements and expectations.

  • Write/update procedures for operations and support training plans.

  • Assists in the periodic inspection of complaints to ensure quality of work and prepare for audit support.

  • Creation of English-language reportsClose cooperation in a multifunctional team and the manager in USA

  • Communication with international subsidiaries and business partners

Your Abbvie Talent:

  • Bachelor’s Degree preferred; preferably in nursing, pharmacy, medical technology, engineering or scientific background (MLT, LPN, RN) or 3-5 years’ experience in a medical device / drug quality function

  • 3-5 years supervisory experience preferred

  • 5+ years of work experience in a cGMP related industry or in a clinical setting (preferred)

  • Excellent problem solving and decision making skills are required. Must be able to identify problems and come up with solutions to problemsto ensure timely and compliant complaint handling decisions.

  • Fluent in spoken and written English

  • Prior knowledge of the handling of complaints, ideally of biological and combination products and experience with Trackwise/Soltraqs, is an advantage - Basic knowledge of pharmaceutical and/or medical device regulations in the USA as well as international authorities - High degree of flexibility and strong inclination to work in a team motivation

We Offer .

  • A fantastic opportunity to work in in a world-classteam.

  • A supportive environment that allows you to focus onyour role and tailor your work to your individual needs, including flexiblework models, multiple benefits, and comprehensive health and sports programs.

  • Attractive compensation and company benefits, includingour excellent occupational health management system, which is one of the bestin Germany.

Your Application

  • We are looking forward to your online application.

  • An equal opportunity employer. AbbVie welcomes andencourages diversity in our workforce.

  • Learn more about AbbVie Deutschland atwww.abbvie.de. Visitwww.abbvie-care.defor more informationabout the therapeutic areas in which we’re active.

Additional Information

  • Travel: Yes, 5 % of the Time

  • Job Type: Experienced

  • Schedule: Full-time

  • Shift: Day Job

  • Job Level Code: IC

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