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.The Advisor-QA Quality Systems and Regulatory Compliance role is part of the Lilly Pharmaceutical Delivery Systems (PDS) Quality Systems and Regulatory Compliance team. The team provides support and oversight of the Lilly PDS Devices network of global sites and internal/external suppliers. This role shall provide key expertise to the network and team on application of existing and new standards, regulations, and guidance with regards to medical devices and device constituents of combination products within the Lilly portfolio.The Advisor QA-IDM (Quality Systems and Regulatory Compliance) will report to the Quality Senior Director and will have responsibility for coordinating the development and maintenance of Technical Files and Technical Documentation for new and existing products, external surveillance and intelligence on global device regulations, CE marking support of new devices. This role also supports hosting of regulatory inspections and performing quality system gap analyses against existing and upcoming new regulations. Additionally, this role may have responsibility for assessing Pharmaceutical Delivery Systems (PDS) functional areas, contract manufacturers, applicable affiliates and ISO certified sites as an auditor (as assigned based upon business need) against the PDS Quality Management System to ensure that processes are robust and in compliance with the PDS QMS, ISO 13485 requirements and applicable global medical device and combination product regulations.Responsibilities:
Lead and coordinate PDS/IDM impact analysis of global regulatory changes and Lilly Quality Standards
Coordinate development and maintenance of Technical File and Technical Documentation
Support CE marking of new products
Create and maintain applicable quality system SOPs
Lead/Conduct audits as assigned
Create audit reports
Review audit responses and verify implementation of corrections, corrective actions and preventive actions
Provide support for audits by internal (GQAAC) and external (Notified Body, FDA etc.) auditing bodies
Support organizational continuous improvement initiatives
Basic Qualifications:
Bachelors Degree preferred
5 years’ experience in Quality or Regulatory Affairs preferred
In-depth knowledge of internal standards, applicable external medical device and combination product global regulations and ISO 13485
Experience with conducting audits
Ability to influence diverse groups
Ability to work independently
Attention to detail
Problem solving and decision-making skills, with emphasis on data-based decisions, and customer service
Strong written and verbal communications skills
Strong administrative and organizational skills
Teamwork and interpersonal skills
Additional Skills/Preferences:
Auditor certification (ASQ CQA) and/or Regulatory Affairs Certification (RAC, RAPS)
Experience with Microsoft Applications, SAP, Veeva, and TrackWise
Additional Information:
Travel up to 10% of the time (Including International)
This position is located in Indianapolis, Indiana, and is classified as flexible/hybrid
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.#WeAreLilly
