Sr Principal Associate - Qa, Quality Management Systems Deviation Lead - Parenteral Network

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Position Description

The Sr Principal Associate - QA, QMS Deviation Lead - Parenteral 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 Parenteral 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 - Parenteral Network is responsible for:

• General QMS responsibilities
  • Be a change agent for the One Lilly QMS transformation program advocating for its adoption within the Parenteral 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 Parenteral network including facilitation of cross-functional education sessions and training programs.
  • Support deployment activities for Parenteral sites globally.

• Deviation Specific responsibilities
  • Consult with key Parenteral Network stakeholders to generate an ideal future state process map for Deviation Management
  • Support 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 Parenteral 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 Parenteral SMEs to support as necessary.
  • Support development of deployment plans within Parenteral network and more broadly to all business areas around the company as necessary
  • Act as primary deployment lead for Parenteral Network globally, ensuring adequate local site representation is available for full site deployment.
  • Support overhaul of Parenteral 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 Parenteral specific documentation and training content in collaboration with training SME and system integrator SMEs.
  • Escalate Parenteral 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 Qualifications

• BS, 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 preferred
• Demonstrated 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 Information

• Ability to travel (domestic and internationally).
• Potential for role to be based at any Lilly M&Q site. 

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