Advisor/senior Advisor

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.

$121,500 - $198,000

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
- 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
- Ability to work independently and as part of a team with mínimal 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 ar