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Lead Quality Associate in R&D
vor 3 Monaten
Join Elanco – A Leader in Animal Health
At Elanco (NYSE: ELAN), we are committed to enhancing the lives of animals and the people who care for them. As a pioneering organization in the animal health sector, we focus on innovation and the delivery of effective solutions to prevent and treat diseases in both farm animals and pets. Our mission is encapsulated in our vision of 'Food and Companionship Enriching Life' and our sustainable approach known as the Elanco Healthy Purpose, which aims to improve the health of animals, people, the planet, and our business.
We believe that a diverse and inclusive workplace fosters creativity and drives success. At Elanco, you will be part of a culture that encourages fresh perspectives, collaboration with dynamic individuals, and opportunities for professional growth.
Enhancing animal welfare enriches human life – become a part of our team
Key Responsibilities:
- Provide leadership in quality assurance for global R&D functions and project teams, facilitating new product development and launches.
- Establish strong partnerships and influence R&D teams to ensure compliance with Elanco's quality strategy and regulatory standards.
- Proactively identify and implement solutions to enhance quality compliance through effective monitoring and improvement of Elanco Quality Systems.
- Lead initiatives in quality excellence across global R&D and QA teams, focusing on cGMP and supporting quality metrics.
- Engage with Health Authorities regarding R&D GMP activities and assist in local inspections.
- Collaborate with scientific and business teams to evaluate and improve global project outcomes.
- Build and maintain relationships with internal and external stakeholders in R&D and Quality.
- Apply scientific expertise to address quality challenges and provide tailored solutions.
- Guide R&D project teams throughout the development lifecycle.
- Review and approve GxP documentation related to manufacturing and registration processes.
- Support the establishment and enhancement of the quality system in line with the Elanco Quality Manual.
- Deliver quality and compliance training to R&D teams.
- Oversee local quality compliance audits and maintain quality agreements with third parties.
- Ensure compliance with all company policies and global quality standards.
- Perform additional duties as assigned by management.
Qualifications:
Education: Degree in Life Sciences or a related field (Chemical Engineering, Pharmacy, Biology, Biotechnology, Chemistry).
Experience:
- 7+ years in Quality Assurance, Quality Control, or a related technical field.
- Strong background in pharmaceutical manufacturing and/or R&D.
- Familiarity with Quality Systems and processes.
- Proficient in MS Office applications.
- Ability to prioritize and manage multiple tasks effectively.
- Excellent interpersonal skills and ability to influence outcomes positively.
- Strong communication skills in both English and German.
Preferred Qualifications:
- Capability to obtain QP/IVP/IMP certification.
- Experience in risk assessment methodologies.
- Auditing experience.
Additional Information:
- Expected travel: up to 10-20%.
- Functional leadership role involving external and internal resources.
