Director of Quality - External Manufacturing (Teleworker)
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.
This role will provide leadership and oversight to a team of EEM Quality Assurance staff responsible for the quality oversight of third party CMOs manufacturing product for Elanco Animal Health Inc. ensuring they are effective and compliant with the regulatory and company requirements. It will also be driving continuous improvement of quality systems and processes pertaining to external manufacturing. The incumbent will have oversight of external partners located primarily in the United States and Canada.
- Leading a team of QA Consultants and Associates working within the US which includes duties such as: Setting priorities, assigning of duties, performance monitoring and management, staff training and development.
- Ensuring that the team members follow internal company requirements, such as Ethics & Compliance, HSE and Finance, and demonstrating commitment to company values with a high level of demonstrated professionalism, integrity, and trust.
- Ensuring all staff are qualified and that the required initial and continued training of all quality personnel is carried out and adapted according to the needs.
- Being responsible for Quality oversight to external suppliers and third parties manufacturing products for Elanco to ensure that the delivered products comply with valid quality standards and legal requirements.
- Enabling the robust selection and onboarding of third-party manufacturers or suppliers in compliance with both the regulatory/GMP requirements in alignment with Elanco Global Quality Standards and Procedures.
- Ensuring appropriate application of quality risk management for third party oversight.
- Supporting product launches and manufacturing site transfers in compliance with internal and external requirements.
- Ensuring Quality input to and evaluation of qualification and validation activities at third party manufacturers.
- Proactively monitoring Key Performance Indicators (KPI) for suppliers and contractors to detect and address quality signals before compliance issues arise.
- Ensuring in association with other relevant personnel that Product Quality Reviews/Annual Product Reviews are completed according to the required timelines.
- Implementing continuous improvement initiatives associated with quality systems to ensure they are both robust and effective and enable appropriate levels of supplier monitoring and product quality performance.
- Engaging with Elanco Global Quality Auditing and Compliance (EGQCA) to prepare for audits and manage CMOs relationships to ensure completion of appropriate CAPA plans.
- Ensuring 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.
- Engaging in resolution of manufacturing deviation investigations and CAPA identification to prevent reoccurrence. Manage and support Change Control activities. Complete Notification to Management as required for quality issues.
- Partnering with Regulatory, Technical Services & Manufacturing Sciences, Operations and external partners on technical matters, submissions and timely completion of regulatory commitments.
- Supporting resolution of product complaints through collaboration with internal subject matter experts and external partners.
- Coordinating actions that seek productivity.
- Approving the GMP documents ensuring the technical rigor of documentation.
- Establishing, monitoring and managing the expenditure in order to achieve the Business Plan.
- Bachelor’s degree in pharmacy or life science related field
- Minimum 10 year experience in pharmaceutical industry and QA operations
- Thorough knowledge in Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and regulatory requirement
- High flexibility to adjust quickly and effectively to frequent change and altered priorities, and ability to work under pressure and compliance with strict deadlines
- Knowledge of Quality Control, technical experience in manufacturing
- Experience with SAP and other Pharmaceutical Software systems such as Veeva
- Knowledge of MS Excel, Word and Power Point
- Direct reports: approx. 8
- Travel: 20%
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
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