Director-Quality Control for pharmaceutical industry (m/w/d)

Elanco Clinton Laboratories

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Kiel, DE

Job Description

As posted by the hiring company

Job Overview:

As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.

The QC Director, working with all members of the leadership team and reporting to the Site Head of Quality, will lead the planning and managing of long term site quality goals for the QC department. Quality Control responsibilities include managing and providing strategic guidance to approximately 90 employees in accordance with regulatory guidelines and Elanco quality standards. This role partners closely with other QC departments within Elanco and the Global QC Network team.

Key Objectives/Deliverables:

  • Managing the quality control department, budget, and personnel planning
  • Ensure that the testing of raw materials, packaging materials, bulk materials and finished products is carried out in the appropriate time and according to required GMP/GLP requirements
  • Ensure that process validation, cleaning validation, method validation, transfer of new products and stability testing is performed on time and in alignment with production needs
  • Ensure that test methods are validated, and equipment is qualified to perform the tests
  • Ensure that qualified personnel are available for laboratory management
  • Develop key talents and a strong succession pipeline within the department
  • Share and drive best practices within the QC department and between Elanco sites
  • Monitoring, developing, and improving the quality system for quality control
  • Implement and follow up on the quality objectives (KPls) of the quality control department
  • Define and drive the laboratory's strategic vision in terms of resources, investment, continuous improvement (lean/5S approach) and budget.
  • Promote and foster a culture of continuous improvement within the laboratory
  • Develop and drive a QC productivity Agenda
  • Guarantee safety at the laboratory

Minimum Requirements:

  • A minimum of 10 years of professional experience and technical expertise in pharmaceutical industry, both in Quality Control as well as in Quality Assurance
  • minimum 5 years of experience as a team leader or manager
  • Proven track record of managing budget and employee development
  • Strong expertise with the Global Quality Standards (EU GMP, FDA)

Additional Preferences:

  • Strong interpersonal skills. Ability to work in a cross-functional, multi-national team.
  • Strong analytical skills. Ability to set priorities and manage multiple tasks.
  • Strong proven solution-oriented mindset.
  • Strong focus on continuous improvement and operational excellence. Being open-minded and challenging the status quo, ideally Green Belt.
  • Ability to influence people and to build collaborative relationships both within Elanco and the external environment.
  • Ability to effectively communicate verbally and in writing, fluent in German, and English.
  • Excellent organizational skills.
  • Proficiency with applicable computer systems, such as SAP, Veeva and Microsoft Office

Education Requirements:

  • MSc. in Chemistry, Pharmacy or Pharmaceutical Technology, Biology, Microbiology or comparable. Desirable PhD in the above or equivalent.

Other Information:

  • Monday-Friday, normal flexible hours
  • Travel required occasionally

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status