Manager — R&D Quality & Compliance

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:

Position Description:

This position supports the Research & Development organization by providing site-based leadership for Elanco R&D Quality Assurance (ERDQA) Quality Systems & Compliance (QSC) and ensuring quality and compliance oversight of R&D related functions located at the IAC. 

Your Responsibilities:

The role is responsible to:

• Oversee and manage IAC QSC resources in alignment with R&D Quality vision and R&D priorities to deliver high-impact innovation portfolio.
• Serve as ERDQA lead for onsite R&D business functions including collaborating in a cross-matrixed environment with Clinical Operations, Data Management, Statistics, Global Operations and Transformation, Archiving, CMC Regulatory Affairs, Pharmacovigilance, and IAC site management.
• Facilitate inspection readiness, represent R&D business and ERDQA for Health Authority inspections and internal audits, including influence and defense.
• Serve as core team member for the R&D Digital Innovation Governance team. In collaboration with business and IT, develop and implement Artificial Intelligence (AI)-based strategies and solutions to advance continuous process improvement and efficiencies. Represent ERDQA for R&D AI initiatives.
• Perform Elanco Computer Systems Quality Assurance (CSQA) related activities around the update, integration, and configuration of technology to ensure compliance with relevant standards and regulations.
• Leverage metrics and expertise to drive performance and improvement.
• Develop collaborative partnerships with R&D to establish and resource Site and Global Self-Inspection and Quality Plans.
• Represent R&D Quality on Global Innovation projects as GCP (VICH GL9) and GLP (FDA, EPA, OECD or other) subject matter expert.
• Conduct GCP (VICH GL9) and GLP assessments, audits, and Quality investigations.

Minimum Qualifications:

            Education:

• Master of science in biology, chemistry, pharmacy, toxicology or similar discipline with a minimum of 10+ years relevant experience.

            Experience:

• 5+ years Animal Health development experience, with R&D-related Quality Assurance esp. in Quality Systems, Pharmacovigilance, Regulatory CMC and/or Data Management.
• Ability to operate in a business focused R&D Quality organization recognized as a collaborator and partner to both the R&D organization and CRO business partners.
• Knowledge in GCP (VICH GL9), GLP (FDA, EPA, OECD or other) compliance and Good Documentation Practices (ALCOA+), GPV or GMP experience a plus.  Knowledge in one or more global regulatory requirements (FDA, EPA, USDA, CFIA, MHRA/VMD, EMA).
• Knowledge in regulatory requirements [e.g., Good Clinical Practice guidance (GCP, VICH Guideline 9) and / or Good Laboratory Practice (GLP) and 21 CFR Part 11 (ERES)] as related to electronic records, electronic signatures, and Good Documentation Practices (ALCOA+).
• Applicable knowledge and certifications related to Artificial Intelligence and Machine Learning or willingness to obtain.
• Familiarity with basic database design, Software Development Lifecycle, software validation, User Acceptance Testing (UAT). Elanco Animal Health Computer Systems Quality Assurance Certified preferred.
• Expert knowledge of Computer System Quality Assurance requirements.\
• Preferred qualifications
• Leads small to medium scale projects with minimum to moderate risks.
• Knowledge of business processes and the ability to work within the general business hierarchy.
• Ability to negotiate favorable outcomes while maintaining positive working relationships.
• Aware of risk-assessment methodologies, and project organization.
• Able to interpret regulations and policies, and to communicate and respond to associated questions.
• Ability to define problems, collect and review data, establish facts and draw valid conclusions.
• Ability to effectively communicate verbally and in writing.
• Ability to effectively work with teams.
• Ability to set priorities and manage multiple tasks.

Additional Information:

• Travel: 0%
• Location: IN, Bangalore - Hybrid Work Environment

Don’t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

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