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AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 30,000 people worldwide and markets medicines in more than 170 countries.

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

Manager Calibration & Qualification (all genders)

to support our diverse team.

In this role you are responsible for the qualification and calibration of manufacturing, packaging, logistic and QA Lab Equipment. You also make shure E/F/U and Lab Instrument Qualification and Calibration comply with GMP.

On top of this you provide corporate guidance on activities related to strategic planning, market demand and trends, strategic opportunities and business needs, technological advances and legal requirements.

Does this sound interesting to you?

Then let us tell you more on the role.


Aufgaben
  • Develop strategies for organization and execution of qualifications and calibrations for Operations in compliance with applicable policies and procedures.
  • Revise and improve activities extending across locations within the scope of qualification and calibration with consideration of pharmaceutical regulations and AbbVie internal requirements.
  • Drive global qualification / calibration initatives, participate in global CoE and Cop and align calibaration / qualification approach with global functions.
  • Set standards for compliance with applicable regulatory requirements, policies and procedures regarding qualification and calibration.
  • Anticipate and understand the business needs and have a thorough knowledge of customer strategic needs and translate these into process improvements.
  • Lead and contribute to the development of long-term business and organizational strategies.
  • Ensure availability of skilled resources (internal & external) and budget planning & compliance / allocation for internal and external IME customers.
  • Manage multiple, concurrent business critical projects.
  • Participate in CRB, be responsible for compliant and comprehensive changes with timeliness approval.
  • Check and approve Nonconformity Reports regarding calibration and qualification.
  • Ensure CMMS (Maximo) compliance by calibration related service requests and monitoring of timeliness calibration execution / workorder processing.
  • Provide overall leadership motivation and training to the qualification team and calibration team.
  • Prepare and participate in authority and customer audits regarding qualification and calibration.
  • Support / drive implementation LU site strategies and ensure proper communication among different levels.
  • Foster collaboration between different departments.

Profil
  • Engineering studies completed with a masters degree (diploma) in chemical engineering or a related field of study.
  • Several years of work in Pharma and GMP environment.
  • Minimum 3 years of experience in successful people management.
  • Strong leadership skills and solution-driven style.
  • Understanding of business needs and impact of regulatory issues on these.
  • Sound knowledge and full appreciation of GMP and integrated quality culture.
  • Strong interpersonal skills to negotiate and reconcile differences, while optimizing overall organizational goals.
  • Independent, diligent and responsible way of working.
  • Excellent organization and coordination skills
  • Very good written and spoken English and German language skills.
  • Ability to work independently.

Wir bieten

At AbbVie, we offer you the resources and a global reach to empower your innovative mindset. From day one, we’ve known it takes teamwork and collaboration to develop the scientific breakthroughs, an innovative pipeline, and therapies that change millions of patients’ lives around the world. In short, we know it takes “you” to make those ground-breaking advancements happen. We take pride in serving and supporting our communities and protecting the environment, making a lasting impact that's felt within healthcare and beyond