Director Quality

Education : EQUIVALENTEXPERIENCE

**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.**

**Position Description**:
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. to ensure they are effective and compliant with the relevant regulatory and company requirements. Drive continuous improvement of quality systems and processes pertaining to external manufacturing. The role is based in Basel, Switzerland, with oversight of external partners located primarily in Europe.

**Functions, Duties, Tasks**:
Main Responsibilities
- To lead a team of QA Third Party Managers and Specialists working within the EMEA region which includes duties such as: Setting priorities, assigning of duties, performance monitoring and management, staff training and development
- Ensure that team members follow internal company requirements, such as Ethics & Compliance, HSE and Finance, and demonstrate commitment to company values with a high level of demonstrated professionalism, integrity, and trust.
- Responsible for Quality oversight to external suppliers and third parties manufacturing product for Elanco to ensure that the delivered products comply with valid quality standards and legal requirements.
- Enable 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.
- Support product launches and manufacturing site transfers in compliance with internal and external requirements. Ensure Quality input to and evaluation of qualification and validation activities at third party manufacturers.
- Proactively monitor Key Performance Indicators (KPI) for suppliers and contractors to detect and address quality signals before compliance issues arise.
- Ensure in association with other relevant personnel that Product Quality Reviews/Annual Product Reviews are completed according to the required timelines.
- Implement 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.
- Engage with Elanco Global Quality Auditing and Compliance (EGQCA) to prepare for audits and manage CMOs relationships to ensure completion of appropriate CAPA plans.
- 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.
- Engage 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.
- Partner with Regulatory, Technical Services & Manufacturing Sciences, and external partners on regulatory submissions.

**Minimum Qualification (education, experience and/or training, required certifications)**:

- Bachelor’s degree in pharmacy or life science related field from reputable university
- Minimum 6 -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 able to work under pressure and compliance with strict deadlines
- German, English

**Additional Preferences**:

- Ideally French
- Knowledge of Quality Control, technical experience in manufacturing
- Experience with SAP and other Pharmaceutical Software systems such as TrackWise
- Knowledge of MS Excel, Word and Power Point

**Other Information**:

- Direct reports: approx. 7
- Travel: 10%

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