Sr Principal Associate
4 weeks ago
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.
Position Description
The Sr Principal Associate - QA, QMS Deviation Lead - Dry Product and Device Network represents their network for the One Lilly QMS transformation program, modifying the way we execute core quality processes (e.g., deviations, CAPA, changes, complaints, supplier quality management, auditing) across the Lilly enterprise. The Dry Product and Device Network lead supports design and deployment of our core quality management system processes (with primary focus on Deviation Management), the related eQMS tool, and advanced technological capabilities (e.g., artificial intelligence). This position includes establishing and transforming processes that will sustain compliance and support continuous quality improvements throughout Lilly's GxP operations. The role is a key influencer in the design and implementation of our future transformed QMS.
Key Objectives/Deliverables:
The Sr Principal Associate - QA, QMS Deviation Lead - Dry Product and Device Network is responsible for:
General QMS responsibilitiesBe a change agent for the One Lilly QMS transformation program advocating for its adoption within the Dry Product and Device network.Participate in all required general QMS workshops and team meetings.Provide network specific input to other QMS workstreams as requested.Support general QMS Organizational Change Management activities within the Dry Product and Device network including facilitation of cross-functional education sessions and training programs.Support deployment activities for Dry Product and Device sites globally.Deviation Specific responsibilitiesConsult with key Dry Product and Device Network stakeholders to generate an ideal future state process map for Deviation ManagementSupport the detailed deviation and CAPA design sessions for the One Lilly QMS transformation program, providing network specific inputs and seeking additional network SME input as required. Connect with stakeholders in network and make informed design decisions on behalf of the Dry Product and Device network.Socialize all analytical investigation related changes within their network to ensure broad acceptance of proposed solutions.Be a change agent for the overall future state deviation management system and process advocating for its adoption within their network.Support all necessary validation activities and identify additional Dry Product and Device SMEs to support as necessary.Support development of deployment plans within Dry Product and Device network and more broadly to all business areas around the company as necessaryAct as primary deployment lead for Dry Product and Device Network globally, ensuring adequate local site representation is available for full site deployment.Support overhaul of Dry Product and Device network specific documentation (including providing guidance on local site procedures) and training programs to align with streamlined global approach.Design and deliver global and/or Dry Product and Device specific documentation and training content in collaboration with training SME and system integrator SMEs.Escalate Dry Product and Device specific concerns/issues and develop mitigation plans.Support establishment of Deviation Center for Enablement by designing and delivering deviation related programs globally (e.g. Deviation conferences, enhanced deviation communications, deviation reward and recognition programs etc.)Basic QualificationsBS, MS, or PhD in a field of science, engineering, pharmacy, or medicine.Minimum 10-year experience in the pharmaceutical industry, in areas of cGMPs/cGxP's Additional Skills/Preferences:Extensive hands on deviation management and analytical investigation experience required. Hands on experience with other QMS processes desired.Lean, 6 sigma, Black Belt, or Competitive Continuous Improvement coach experience preferredDemonstrated leadership acumen, including project leadership Demonstrated ability to build and maintain collaborative relationships with external/internal stakeholders; navigate complex issues and find common ground with multiple constituencies with differing, and often opposing, perspectives.Strong collaboration, negotiation, problem solving, and interpersonal skills. Proven record of finding and implementing solutions.Demonstrated ability to write technical documents, develop business presentations, and effectively communicate the concepts to a wide range of personnel.Additional InformationAbility to travel (domestic and internationally).Potential for role to be based at any Lilly M&Q site. 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 ( ) 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
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