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Site Quality Head (m/f) Job

Date: Nov 12, 2017

Location: Burgwedel, NI, DE

Company: MSD

Requisition ID: QUA006240

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


 



MSD’s Animal Health (MAH) division works to improve the health of animals around the world through collaborative partnerships and a deep sense of responsibility towards our customers, consumers, animals, society, and our planet. This team of energetic, independent thinkers offers one of the industry’s most innovative portfolios of products, services, and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species both domestically and internationally.


 



  • Being the people manager for approx. 40-45 members of staff (6 direct reports)

  • Leading Quality Operations (Quality Control, Quality Assurance and Quality Systems) and having overall responsibility for the compliance status related to current EU/FDA GMP requirements, veterinary and human guidelines and MSD policies

  • Being responsible for ensuring quality and business policies, systems, processes and practices are implemented in a sustainable way and kept in place at the site which ensures products are manufactured, packaged, tested, released and marketed in accordance with the current standard as required under the current GMP and all other applicable regulations

  • Ensuring direction to the site quality organization, providing leadership and coaching to the quality team; working on team building and upskilling team members

  • Focusing the Burgwedel manufacturing site (as member of the Site Leadership Team) and quality organization on Quality Systems thinking and Continuous Improvement (Lean Six Sigma methodology)

  • Establishing measures of quality and operational performances designed to advance the performance of each Quality team in its area

  • Directing the preparation of profit plans and capital budgets and maintaining adequate surveillance of actual performance versus budget plan
Qualifications

 



  • Master's degree and / or PHD in scientific discipline

  • 10 to 15 years of experience in the pharmaceutical or biotech Industry at EU/FDA regulated (aseptic) manufacturing sites within the Quality Operations management with demonstrated knowledge of GMPs and compliance requirements

  • Proven leadership and coaching skills and focus on people development

  • Expert knowledge of Quality Systems, Laboratory processes and equipment, Computer System Validation, Quality Assurance, Quality Control, data integrity concepts.

  • Fluency in written and verbal German and English language and proficiency in analytical reporting and technical report writing

 


Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.





Job: Qual Assurance & Ops Generic
Other Locations:
Employee Status: Regular
Travel:
Number of Openings:
Shift (if applicable):
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Company Trade Name: MSD


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