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

Complaint Laboratory Manager m/f/d

Germany, Rhinland-Palatinate, Ludwigshafen

New

Quality Assurance

Requisition #2002493

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 LabAnalysts to include: hiring, setting performance expectations, providingperformance feedback, development of staff and handling of personnel issues.

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

  • Evaluation/approval of complaint data based upon knowledgeand experience, which determines the final outcome of the complaintinvestigation.

  • Independent planning and coordination of investigations toensure timely execution of complaint investigations according to PMQArequirements and expectations.

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

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

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

  • Assists in the periodic inspection of laboratoryfacilities to assure that they are operated andadministered according toindustry complaint lab requirements and good Laboratory Practices.

  • Creation of English-language reports

  • Close cooperation in a multifunctional team and themanager in USA

  • Communication with international subsidiaries and businesspartners

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-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

  • Job Level Code: IC

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