Advisor/Senior Advisor - Regulatory Compliance and Post Market Reporting

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

This position is responsible for providing support across the different regulatory reporting and inspection support that is provided by the Regulatory Compliance & Post Market Reporting team.  This includes but is not limited to; all facets of PAI/PLI inspections, US FDA field alert, Biological product, illegitimate product, global regulatory reporting, support for global recall and US recall activities, monitoring and reporting of US product shortages, coordinate product shortage notification for OUS countries, update drug and device establishment registrations for changes as required including completion of annual changes, gathering and analyzing information for inspections, annual product reviews, periodic reviews, site compliance reports

Key Objectives/Deliverables:

In this role the individual works with the Process Owners across all Regulatory Reporting programs.  The support that they provide to the different programs are as shown below.

Compliance Support

• Lead inspection readiness activities

• Serve as a global compliance CGMP expert providing feedback in preparation for corporate audits, agency inspections, global standard revisions, and changes in local business or manufacturing processes.

• US (Field Alert Report-FAR, Biological Product Deviation Report-BPDR, EUA reporting, Illegitimate Product Report - Form 3911 per DSCSA) and Global regulatory reporting of Quality/safety/compliance issues

• Global and US Recall / Market Withdrawal activities

• Global and US Product Shortage activities

• Drug and Device Establishment Registration activities

• US Volume Reporting activities

Personal Development and Shared Learning

• Attend training courses, conferences, or association meetings to continue to gain knowledge
• Share such information with other members of the team or company to increase awareness and to train others in the implementation of these practices
• Be continually aware of current industry trends and regulatory agency interpretation of GMP and other relevant requirements
• Continue to gain knowledge necessary to provide a greater understanding of GxP requirements
• Participate in applicable external industry groups and forums

Divisional/Global Quality Organization Support

• Participate in projects as directed by Global Quality Compliance leadership that support or enhance GMP Compliance of larger quality organizations; ability to carry out mission and meet objectives
• Participate in projects/work groups as representative of Global Quality Compliance

Minimum Requirements:

• Bachelor’s degree or equivalent experience in a scientific field such as Pharmacy, Chemistry, Engineering or other biological sciences.
• 15+ years relevant Industry/Health Authority experience in areas which may include: technical services, manufacturing operations, quality assurance, quality control or regulatory affairs

Additional Preferences:

• Expertise in utilizing data driven approaches to assess compliance posture of sites
• Broad knowledge of GMPs and quality systems as they apply to pharmaceutical manufacturing and marketing
• Significant experience with supporting global inspections
• Experience with global compliance programs
• Experience in Quality Assurance or GxP function
• Strong compliance knowledge
• Demonstrated ability to communicate and deliver constructive feedback to customers, including excellent oral and written communication and oral presentation skills
• Demonstrated ability to interpret and apply standards to different situations by understanding customer needs and applying good problem-solving skills
• Ability to work independently and as part of a team with minimal supervision

Other Information:

• Maintain awareness of regulatory and industry tends; ensure corporate standards remain current.
• Flexibility to effectively prioritize work activities to meet regulated timelines.
• Demonstrated strong oral and written communication and interpersonal interaction skills, with interaction at multiple levels of the companies.
• Ability to work across functional areas with people at all levels of the organization.
• Ability to influence and negotiate with peers, immediate supervision, site supervision and executive management.
• Organized with attention to detail.
• Multi-tasking and self-management to meet multiple overlapping timelines.
• Proficient in global IT tools such as Track Wise, Regulus, SharePoint.
• Expect 25% travel for supporting inspections, training or conferences.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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