Quality Assurance - Compliance One-QMS Steward

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 QA Compliance One-QMS Steward serves as the site lead overseeing the Quality Management System (QMS) for Central Quality Systems which enables the organization to provide safe and effective products and to meet customer expectations and regulatory requirements.

The QA Compliance One-QMS Steward is responsible for improving business processes and supporting site manufacturing stakeholders to ensure key business objectives are met.

The Principal Associate QA Compliance One-QMS Steward represents Quality Assurance on projects, including lean initiatives.

Finally, the QA Compliance One-QMS Steward is responsible for activities that include non-conformance investigations, change controls, procedure revisions, site impact analysis reviews, review and approval of cGMP documents, and maintaining regulatory compliance of the Central Quality Systems (CQS).

Key Objectives / Deliverables :

• Implement and maintain the RTP Quality Management System overseeing Deviations, CAPA, Batch Release, Change Control, and Product Complaint management
• Effectively manage the transfer of Quality Management System (QMS) from TrackWise platform to the Veeva platform for the RTP site.
• Collaborate regularly with the global One-QMS team to understand key deliverables and assist in their effective execution for the RTP site.
• Compile and present the progress report for the One-QMS initiative to the RTP Site Quality Lead Team and Site Flow Teams with actions, timelines on a routine basis
• Act as Power User / Site Instructor for the new One QMS Veeva system and for programs within the system such as deviations, Change Controls and CAPA.
• Authors, periodic reviews, and acts as Subject Matter Expert for RTP One-QMS Veeva System.
• Support and initiate Veeva Trend, RCI’s, Tasks or other technical investigations, as applicable.
• Engage with site personnel in coaching and mentoring for the One QMS Veeva system and drive product / process improvements and understanding.
• Support the RTP One-QMS Program owners through facilitation of Senior leadership review boards, Deviation review board, Change review board, Management Review and Execution of records.
• Partner cross-functionally with all area / function owners to review data sources that identify existing as well as potential problems and propose continuous improvement.

Requirements / Preferred Attributes :

• Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience.
• At least 10 years working in the pharmaceutical or medical device industry in QA roles.

Preferred attributes, but not required :

• Proficiency with GMP computer systems including Deviation Management systems, and Document Control systems.
• Advanced Technical Proficiency and understanding of end-to-end operations of quality systems within Deviations, CAPA, Batch Release, Change Control, and Product Complaint management
• Previous process leadership, people influencer experience
• Knowledge of regulatory requirements (e.g., cGMP, 21CFR820, ISO13485, Canadian MDR)
• Demonstrated strong oral and written communication and interpersonal interaction skills
• Demonstrated strong technical writing skills.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Previous experience in leading and driving local / global project implementations
• Previous regulatory inspection readiness and inspection execution experience.
• Ability to compile data and metrics in reports understandable by management and business partners.
• Attention to detail, self-management, problem solving; mentoring.
• Previous experience with Quality management systems including TrackWise and Veeva.
• Previous experience with device and parenteral product materials

Other Information :

• Ability to work 8-hour days Monday through Friday is required on site; up to 4 days per month (e.g. 1 day per week) may be WFH applicable.
• May require support outside of regular schedule (weekend days or off-hours) in support of continuous (24 / 7) manufacturing operations.
• Ability to travel up to 5% to Indianapolis, IN for meetings and coordination with global regulatory organizations is required.

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.

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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.

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