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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 Laboratory Manager m/f/d

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Quality Assurance
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2002493 Requisition #
Join our Talent Community

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

 

 

Complaint Laboratory Manager m/w/d

 

The Complaint Laboratory Manager is responsible for the organization, administration, and supervision of 510 lab analysts who perform return sample investigations and functional testing for the Medical Device / Device components of AbbVie products. Further he/she  is responsible for the proper and complete oversight of the day to day operations. This is to include document handling and provides oversight for lab systems and complete documentation of laboratory investigation reports. The Complaint Laboratory Manager is responsible for complaint sample investigation reports, change requests, instrument calibration, instrument maintenance and product records handled in the area.


Key Responsibilities Include:

  • Responsible for the management and oversight of Lab Analysts to include: hiring, setting performance expectations, providing performance feedback, development of staff and handling of personnel issues.

  • Responsible for the operation and functions of the laboratory group which includes investigation of returned Medical Device and Device component complaint samples (potentially infectious material) from international markets.

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

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

  • Identifies aspects of the tests or results warranting further attention and implement corrective actions.

  • Write/update procedures for operation, calibration and training of laboratory instrument as well as laboratory practices.

  • Auditing and maintenance of all laboratory procedures and instrumentation. Ensure inventory of laboratory supplies.

  • Assists in the periodic inspection of laboratory facilities to assure that they are operated and administered according to industry complaint lab requirements and good Laboratory Practices.

  • Creation of English-language reports

  • Close 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 related experience in a 3 medical device / drug quality function

  • 3-5 years supervisory experience preferred (preferably for a laboratory e.g. device failure analysis lab or servicing) or in a similar role

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

  • Problem solving and decision making skills are required. Must be able to help identify solutions to problems impeding timely investigation of complaints and make well educated timely decisions.

  • Must be able to interpret and evaluate complaint investigation data and come to an appropriate conclusion.

  • Fluent in spoken and written English

  • Prior knowledge of the handling of complaints investigations, 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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