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 QA Compliance Program Lead serves as the site lead overseeing the RTP Deviation program which is part of the overall Quality Management System (QMS) which enables the organization to provide safe and effective products and to meet customer expectations and regulatory requirements.

The QA Compliance Program Lead is responsible for improving business processes and supporting site manufacturing stakeholders to ensure key business objectives are met. The Sr. Principal Associate – QA Compliance Program Lead represents Quality Assurance on projects, including lean initiatives. Finally, the QA Compliance Program Lead 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.

Key Objectives/Deliverables:

• Implement and maintain the RTP Deviations and CAPA program per Global Quality Standard (GQS) 104, Deviation Management and Corporate Quality Practice (CQP) 101-3, CAPA Program

• Facilitate the RTP Site Deviation review board providing board leadership to drive complete root cause investigations and assigning corrective and preventive actions to eliminate the root causes of a detected issue or other undesirable situation to prevent reoccurrence.

• Partner cross-functionally with all area/function owners to review data sources that identify existing as well as potential problems and propose continuous improvement.

• Compile and present Deviation and CAPA program health metrics to the RTP Site Quality Lead Team and Site Flow Teams with proposed actions.

• Implement and oversee site Deviation Mentor program.

• Act as Site Instructor for Deviation Management and associated TrackWise 1000 Deviation Module roles.

• Authors, periodic reviews, and acts as Subject Matter Expert for RTP site Deviation and CAPA Management procedures.

• Support and initiate TrackWise Trend, RCI’s, Tasks or other technical investigations, as applicable.

• Engage site personnel in the relationship between the Deviation program and resulting product/process improvements and enhanced product/process understanding.

Requirements (Education, Experience, Training):

• Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study.

• At least 5 years working in the pharmaceutical or medical device industry in QA roles.

Preferred attributes but not required:

• 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 Deviation/CAPA management systems including TrackWise.

• Previous experience with device and parenteral product materials

• Proficiency with GMP computer systems including Deviation Management systems, and Document Control systems.

• Technical knowledge of quality systems

• 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 regulatory inspection readiness and inspection execution experience.

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.

This job specification is intended to provide a general overview of the job requirements at the time it was prepared.  The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification.  As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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.

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