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About AbbVie

AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.  For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.​

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Complaint Handling Manager m/f/d

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Quality Assurance
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2002483 Requisition #
Join our Talent Community

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 problems  to 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-class team.

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

  • Attractive compensation and company benefits, including our excellent occupational health management system, which is one of the best in Germany.

 

Your Application 

  • We are looking forward to your online application.

  • 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.

Equal Employment Opportunity Employer

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients.  As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

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