N: ElancoAnimalHealthInc
Lead the Elanco External Manufacturing (EEM) Quality Unit International Hub. Maintain quality oversight of a diverse product portfolio supported by third party suppliers and contract manufacturing organizations (CMOs) in Europe, Middle East, Africa, Asia, Australia, and New Zealand. Ensure compliance to corporate global standards, health authority expectations, and GMP requirements.
Main Responsibilities:
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To lead the EEM International Quality Unit personnel including Affiliate Switzerland. Establish individual development plans. Partner with HR on talent management and succession planning.
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To have the QA oversight on external suppliers and third parties manufacturing product for Elanco and ensuring, that the delivered products comply with valid quality standards and legal requirements.
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To ensure that all required quality systems for the import, export and release of pharmaceutical products are in place (e.g. change control, complaint handling, deviation and CAPA handling, release documentation review) and meet GMP requirements.
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To ensure the evaluation and approval of new suppliers and contractors according to Elanco and legal requirements is performed. Established suppliers and contractors to be monitored on Key Performance (KPI/QPI) and GMP auditing outcomes.
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To request, review and take initiatives from Quality Metrics and work on continuous improvements of the Quality in EEM international regions.
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To provide quality oversight to Technology Transfers, product launches, and other technical agenda projects. Participate in business development due diligence audits, as needed.
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To ensure that all necessary QA instruments for the sourcing of GMP products from suppliers and contractors (e.g. Quality Agreements, Supplier Risk Assessments, Product Quality Reviews) are in place.
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To represent the commercial quality function in local and global committees and give QA support in project and expert teams for all quality-related matters as product transfers to new suppliers and contractors.
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Manage quality spend to achieve business plan targets.
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To liaise with Health Authorities in all quality related matters as reportable product quality incidents or recalls.
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Define and measure Key Performance Indicators for EEM Quality International. Drive continuous improvement action plans based on signals from performance metrics.
Minimum Qualification (education, experience and/or training, required certifications):
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Formal education in Science (Diploma, Master or equivalent education)
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Minimum 15 years of experience in local and global QA operations
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English
Additional Preferences:
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Act as Fachtechnisch Verantwortliche Person (FvP) at site Basel according to Arzneimittel-Bewilligungsverordnung (AMBV) Art. 5 & 10 and QA lead for commercial Elanco Tiergesundheit AG Switzerland activities. The role assures that all products imported in, exported from or released to Switzerland comply with quality and legal requirements.
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Additional language preferences: German, French
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
