Advisor -Regulatory Compliance and Post Market

Role Summary

This position is responsible for providing GMP/GxP support across the different regulatory reporting and inspection support that is provided by the Regulatory Compliance and Post Market Reporting (RCPMR) team. This includes but is not limited to all facets of inspections for global Health Authorities, HA reporting, and support for global recalls, product shortages, and establishment registrations. Primary focus is compliance support; other duties will depend on business needs.

Responsibilities

• Lead inspection readiness activities
• Serve as a global CGMP expert providing feedback in preparation for corporate audits, agency inspections, global standard revisions, and changes in local business or manufacturing processes
• Proficient in application and use of machine learning and analytical tools to remain continuously inspection ready
• Work with numerous stakeholders to ensure HA reporting as required to meet all global regulations/requirements
• Coordinate US product recall and withdrawals activities and monitor recall activities of partner organizations globally
• Participate in periodic product withdrawal/recall simulations and train local recall coordinators on the process
• Coordinate and execute product shortage reporting for US and OUS, coordinating with supply chain, Global Quality Leaders, Legal, Regulatory, and others, and maintain documentation
• Determine information required for drug and device establishment registrations and update registrations as required
• Coordinate and execute annual volume reporting for US
• Maintain awareness of current industry trends and regulatory interpretation of GMP and related requirements; participate in external industry groups

Qualifications

• Required: Bachelor's degree in a scientific field (preferred: Pharmacy, Chemistry, Engineering or other biological sciences); minimum of 5 years 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; data-driven approaches to assess site compliance; experience in Quality Assurance or GxP; strong compliance knowledge; excellent communication/presentation skills; ability to interpret/apply standards; ability to work independently and with minimal supervision; significant experience supporting global inspections and compliance programs

Education

• Bachelor‚Äôs degree in a scientific field (pharmacy, chemistry, engineering, or related biological sciences preferred)

Additional Requirements

• Travel availability (domestic and international) when required, estimated at 25% or more based on business needs
• Role can be remote or based at any Lilly site/affiliate; preference for site/headquarters