Third Party Quality Assurance Manager API

Responsibilities

• Lead quality oversight and governance of assigned API CMOs and suppliers, ensuring all delivered APIs meet legal, regulatory, and internal Elanco quality requirements.
• Drive supplier qualification, onboarding, audit readiness, quality plan execution, and ongoing compliance with GxP, GMP, and global quality standards.
• Perform QA Authorized Person release responsibilities for APIs shipped to internal and external formulation sites.
• Partner with internal stakeholders, external partners, and network leadership to resolve quality issues, manage escalations, and implement continuous improvement and risk mitigation plans.
• Support new product launches, analytical method transfers, validations, remediation activities, and quality system enhancements across the API network.
• What You Need to Succeed (minimum qualifications):
• Education: Bachelor's Degree or higher in Life Sciences, Chemistry, Pharmacy, Animal Health, or a related discipline
• Experience: A minimum of 8 years of GxP experience in Animal Health, Pharmaceutical Quality Assurance, Quality Control, or a related technical field
• Top 2 skills: Strong knowledge of quality systems / regulatory compliance and demonstrated quality risk management / problem-solving capability
• What will give you a competitive edge (preferred qualifications):
• Previous line management or team leadership experience
• Experience managing third-party manufacturers / supplier quality oversight
• Strong project management and stakeholder management capabilities
• Experience supporting analytical method validation, transfer, and remediation
• Fluency in English; additional language capabilities are an advantage
• Additional Information:
• Travel: Up to 20-30% annually (estimated, depending on supplier and site requirements)
• Location: Bangalore, India
• Flexibility to collaborate across multiple time zones with global stakeholders is required
• 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

Benefits

Additional Information

At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals' lives better makes life better - join our team today! Your Role: Third Party Quality Assurance Manager, API As the Third Party Quality Assurance Manager, API, you will be part of the EEM API Network Quality team, responsible for ensuring robust quality oversight of assigned API Contract Manufacturing Organizations (CMOs) and suppliers across the Indian sub-continent. In this role, you will be responsible for driving GMP and regulatory compliance, supporting compliant API supply to internal and external formulation sites, and partnering cross-functionally to strengthen supplier quality systems, risk management, and continuous improvement initiatives.

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