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Senior Quality Associate-Quality Assurance

vor 2 Monaten

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

At Elanco, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. Our vision is to advance the health of animals, people, the planet, and our enterprise.

Job Summary

We are seeking a Senior Quality Associate-Quality Assurance to provide quality leadership and support for global R&D functions and project teams. The successful candidate will develop strong partnerships and positively influence the various R&D functions and project teams to provide guidance and support on overall quality strategy and to meet requirements of both Elanco and applicable regulatory authorities.

Key Responsibilities
  • Provide quality leadership to R&D functions and project teams at a global level.
  • Drive quality excellence in global R&D and QA teams with focus on cGMP, oversight, and support components of site and global Q plans.
  • Support local interactions with health authorities regarding R&D GMP activities and host local HA inspections.
  • Collaborate and evaluate scientific, business, and quality aspects of global projects and procedures to positively influence business partners and outcomes.
  • Build strong relationships with internal and external business partners in R&D, TS/MS, CMOs/TPOs, and Quality.
  • Apply technical experience and scientific knowledge to find customer-oriented and fit-for-purpose solutions for projects and process challenges around quality issues.
  • Provide guidance to and support R&D project teams throughout the entire development program.
  • Scientific and compliance review and approval of GxP documentation for manufacturing and registration, 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, with particular focus on procedures and SOP systems in R&D Technical Development.
  • Provide and develop quality and compliance training to R&D teams.
  • Support local quality for compliance audits and QA oversight at the local site, for global R&D, and for GxP qualification and oversight activities at third parties.
  • Responsible for maintenance of Quality Agreements with third parties for development activities where required.
  • Qualified to release investigational material and other development material as per Elanco Quality requirements.
  • Comply with all company local and global policies, including Elanco Global Quality Standards, Red Book, and HSE policies.
Requirements
  • Education: Degree in Life Sciences and relevant experience in Technical Area (Chemical Engineering, Pharmacy, Biology, Biotechnology, Chemistry).
  • Experience: 7+ years in Quality Assurance, Quality Control, or related technical field (Pharmaceutical Development, Manufacturing, Chemical Engineering, etc.).
  • Strong background in pharmaceutical manufacturing and/or R&D.
  • Experience with Quality Systems, processes, and training.
  • Knowledge of PC tools, including all MS Office applications.
  • Ability to set priorities and manage multiple tasks.
  • Effective interpersonal and team-building skills, ability to influence without authority to drive favorable outcomes while maintaining positive working relationships.
  • Ability to interpret regulations and policies and make recommendations.
  • Ability to work effectively with teams.
  • Excellent communication skills.
  • Fluent in German and English.
Additional Preferences
  • Ability to become QP/IVP/IMP certification.
  • Skilled in risk-assessment methodologies.
  • Auditing experience.