Sr./Principal Associate- QA Site Program Owner

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Job description

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.

Company Overview:

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 39,000 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.

Organization Overview:

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, start up, and maintain the facility for both clinical and commercial supply. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.

The Quality Assurance Program Owner oversees critical site quality management systems, such as deviation management, change control, complaint management, and corrective/preventive actions. During the delivery phase of the project, the QA Program Owner will be the primary LP2 representative in support of corporate initiatives to standardize key quality systems into common global framework/procedures. As the standardized system is defined and implemented at the Site, this individual will be responsible for any required local procedures/training materials, facilitating review meetings, and tracking program performance per related Quality standards. Additionally, the Program Owner will collaborate on site inspection readiness and participate in regulatory inspections as required.

Responsibilities:

• Consult with Network and Global quality groups as required to ensure effective LP2 Site deployment of global Quality Management System initiatives
• Own and maintain site procedures/training materials, facilitation of review meetings, and tracking program performance
• Provide guidance for deviations, observation handling; change control proposals; document creation and revisions.
• Support the site organization in building technical capability for a diverse cross-functional project team and Quality staff including mentoring and training of new staff members
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
• Lead project initiatives needed in support of the project and Quality function
• Resolve or escalate any compliance issues to the project, site, and Quality Management
• Support and participate in regulatory inspections

Basic Requirements:

• Bachelor's degree in relevant field of study
• 3+ years working in the pharmaceutical manufacturing industry in Quality Assurance roles
• Previous in-depth experience with execution and oversight of Quality Management Systems including deviation, change control, CAPA, and complaints

Additional Preferences:

• Demonstrated knowledge of cGMP practices and regulations including good documentation practices, data integrity and regulatory compliance
• Demonstrated ability to collaborate cross-functionally with strong written and verbal communication, problem-solving, and crisis management skills.
• Demonstrated ability to effectively organize/prioritize work and meet critical deadlines.
• Previous technical writing experience
• Technical aptitude and ability to train and mentor others
• ASQ Certified
• Computer System Quality Assurance experience
• Previous facility or area start up experience
• Previous experience with gene therapy drug substance processes such as equipment prep, virus prep/banking, inoculation, purification, and/or drug product manufacturing processes such as formulation, filling/visual inspection, and packaging
• Previous experience with Manufacturing Execution Systems.
• Previous use of KNEAT - or other electronic validation software

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 ( ) 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.

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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