Senior Quality Associate

Vor 2 Tagen


Monheim am Rhein, Nordrhein-Westfalen, Deutschland Elanco Vollzeit
About Elanco

At Elanco, we're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the planet and our enterprise.

We pride ourselves on fostering a diverse and inclusive work environment, where innovation and creativity thrive. Our team is passionate about making animals' lives better, and we're committed to delivering high-quality products and services to prevent and treat disease in farm animals and pets.

Job Summary

We're seeking a highly skilled Quality Assurance Specialist to join our global R&D team. As a key member of our quality leadership team, you'll provide guidance and support to R&D functions and project teams, ensuring compliance with regulatory requirements and company standards.

Key Responsibilities
  • Provide quality leadership and support to R&D functions and project teams, ensuring compliance with regulatory requirements and company standards.
  • Develop and implement quality systems, processes, and training programs to drive quality excellence in global R&D and QA teams.
  • Collaborate with internal and external stakeholders to ensure effective communication and coordination of quality-related activities.
  • Conduct scientific and compliance reviews of GxP documentation, including pre-clinical, clinical, and CMC protocols and reports.
  • Work with teams to establish, maintain, and improve the quality system in accordance with the ELANCO Quality Manual.
  • Provide quality and compliance training to R&D teams and support local quality for compliance audits and QA oversight.
Requirements

We're looking for a highly skilled and experienced Quality Assurance Specialist with a strong background in pharmaceutical manufacturing and/or R&D. You'll need to have:

  • 7+ years of experience in Quality Assurance, Quality Control, or a related technical field.
  • Strong knowledge of quality systems, processes, and training.
  • Ability to interpret regulations and policies and make recommendations.
  • Excellent communication and interpersonal skills.
  • Fluency in English and German.
What We Offer

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you're passionate about quality and committed to excellence, we'd love to hear from you



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