(Archived) Sr. Quality Advisor - R&D Technical Development

Position Description

As a member of the globally integrated Elanco R&D Quality Assurance (ERDQA) Team, the ERDQA Senior Quality Advisor is accountable to provide quality and scientific technical guidance and oversight of the R&D portfolio, supporting new product development, registrations, licensing, technical transfers, and product launches (GMP, USDA, EPA).

Functions, Duties, Tasks

• Quality oversight of formulation and analytical technical development activities, from early to late development through registration.

• Support quality excellence focus on Pharmaceuticals and Biologics. Be a champion for continuous improvement in all aspects of quality management.

• Strong knowledge of the Quality systems and provides interpretation of the quality management system and applicable regulations to business partners to guide product development activities. Consult and advise project teams on matters related to adherence to regulations for development of products for registration by the FDA, EPA, USDA, EMA, and other regulatory authorities.

• Demonstrated ability to conduct scientific and compliance review and approval of regulated reports (e.g., manufacture of investigational veterinary product, engineering, and registration batches). Qualified to release investigational study material and other development material as per Elanco Quality requirements.

• Support R&D Quality for Technical Development Project and Stage-Gate reviews, technical transfers; serve as project core team member.

• Collaborate with cross-functional teams (e.g., Technical Development, Regulatory, TS/MS, Clinical Development, project management) to ensure program goals are met.

• Lead and guide preparation activities for regulatory authority inspections and/or internal audits to ensure inspection readiness.

• Accountable for maintenance of R&D Quality Agreements where required.

• Supports and executes components of R&D Global Quality and Self Inspection plans

• Management of change control, deviations, CAPAs and out of specifications.

• Independently and appropriately escalates issues to Elanco quality and/or R&D management.

• Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination/harassment and health, safety, and environment policies.

• Perform any other duties or serve in such other capacity as may be determined by management.

Minimum Qualifications

• Bachelors or Master's degree (Chemistry, Biology, Engineering, Pharmacy or Pharmaceutical Technology) or demonstrated career experience in life science.

• 5+ years of experience in the pharmaceutical / biologics industry with strong track record of technical expertise.

• Strong working knowledge of quality systems and regulatory requirements across multiple health authorities.

• Fundamental understanding of pharmaceutical and biologics discovery, development, and registration.

• Expert in reviewing and writing technical reports.

• Strong prioritization and communication skills, experience in working with interdisciplinary, multicultural teams.

• Strong understanding and practical application of risk assessment and risk management tools.

Additional Preferences:

• Fluent in mulitple languages

• Animal health experience

• Auditing experience

Other Information:

• Travel: up to 20%