Advisor -Regulatory Compliance and Post Market

Role Summary

This position provides GMP/GxP support across regulatory reporting and inspection activities conducted by the Regulatory Compliance and Post Market Reporting (RCPMR) team. Responsibilities include management of inspections by global Health Authorities, HA reporting (FAR, BPDR, OUS), support for global and US recalls, monitoring and reporting of US product shortages, and updating drug and device establishment registrations as needed.

Responsibilities

• Lead inspection readiness activities
• Serve as a global CGMP expert, providing feedback for corporate audits, agency inspections, global standard revisions, and changes in local processes
• Apply machine learning and analytical tools to maintain a state of inspection readiness
• Collaborate with multiple stakeholders to ensure HA reporting requirements are met globally
• Coordinate US product recall and withdrawal activities and participate in recall simulations
• Train and advise local recall coordinators on the process for product removal
• Monitor recall activities of partner organizations globally and provide information for periodic reviews
• Coordinate and execute product shortage reporting for US and OUS, documenting decisions and maintaining shortage documentation
• Determine and update information for drug and device establishment registrations, including annual registrations
• Coordinate and execute annual US volume reporting
• Maintain awareness of industry trends and regulatory interpretations of GMP; pursue ongoing GxP knowledge
• Participate in external industry groups and forums

Qualifications

• Required: Bachelor‚Äôs degree in a scientific field (e.g., Pharmacy, Chemistry, Engineering, or other biological sciences)
• Required: Minimum of 5 years of relevant industry or Health Authority experience in areas such as technical services, manufacturing operations, quality assurance/control, or regulatory affairs
• Preferred: Broad knowledge of GMPs and quality systems for pharmaceutical manufacturing and marketing
• Preferred: Expertise in data-driven approaches to assess site compliance
• Preferred: Experience in Quality Assurance or GxP functions
• Preferred: Strong compliance knowledge
• Preferred: Excellent communication and presentation skills with the ability to provide constructive feedback
• Preferred: Ability to interpret and apply standards across diverse situations with strong problem-solving skills
• Preferred: Ability to work independently and collaboratively with minimal supervision
• Preferred: Significant experience supporting global inspections and compliance programs

Skills

• GMP/GxP knowledge and quality systems expertise
• Data-driven approach to regulatory compliance and site assessment
• Strong communication and presentation abilities
• Problem-solving and analytical thinking
• Ability to work independently and collaboratively
• Experience supporting global inspections and compliance programs

Education

• Bachelor‚Äôs degree in Pharmacy, Chemistry, Engineering, or related biological sciences (required)

Additional Requirements

• Willingness and ability to travel domestically and internationally (estimated up to 25%, may vary)
• Role can be remote or based at any Lilly site/affiliate; preference for site/headquarters