Sr. Manager - Quality Assurance

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.

This role is responsible for QA technical oversight including document approvals (e.g., Commissioning and Qualification Packages, procedures) and cross-functional decision making. The Senior Manager, Quality Assurance will develop the quality on the floor programs to support GMP manufacturing. The Senior Manager, Quality Assurance will assist with developing the training program for floor support and training QA personnel.

Responsibilities:

• Serve as technical resource to review and approve technical documents.

• Network with cross-functional technical project delivery team to ensure equipment and systems comply with quality requirements and are implemented with a Quality by Design framework.

• Work with the LKC Quality Managment team to support the development of the vision, strategy and quality culture for the overall site quality assurance organization with focus on the formulation, filling, and inspection processes.

• Support initial recruiting, build capability, for a diverse leadership and quality assurance staff to support qualification, validation and routine production.

• Manage a team of approximately 14 direct reports.

• Support Manufacturing and Inspection by assessing risks of deviations, non-conforming material etc., in real time.

• Support the site to ensure a safe work environment including supporting and leading safety efforts for your team.

• Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures and controls.

• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.

• Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment.

• Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc.

• Network with global and other parenteral sites to understand best practices and share knowledge.

• Work cross-functionally with the area process teams for metrics reviews, operational support, and issue/deviation management.

• Support inspection readiness activities.

• Interact with regulatory agencies during inspections regarding cGMP issues.

• Ensure data integrity by design.

Basic Qualifications:

• Bachelor's degree required. Prefer degree in science, engineering, pharmaceutical-related field of study.

• 5+ years in pharmaceutical leadership with specific QA experience, including leading or working effectively with a cross-functional group.

Additional Skills/Preferences:

• Commit to successfully maintain Lilly Computer System Quality Assurance (CSQA) Certification

• Strong knowledge of Quality Management Systems and applicable regulatory requirements

• Previous experience directly supporting a pharmaceutical manufacturing operation.

• Strong technical aptitude and ability to train and mentor others.

• Demonstrated technical writing skills.

• Previous facility or area start up experience.

• Previous equipment qualification and process validation experience

• Previous experience with highly automated combination products and packaging equipment

• Previous experience with Manufacturing Execution Systems and electronic batch release

• CQM, CQE, or CQA certification from the American Society for Quality (ASQ)

• Previous experience with deviation and change management systems including Trackwise. MasterControl, or alike QMS platform.

Additional Information:

• Ability to work 8-hour days – Monday through Friday

• Ability to work overtime as required.

• Ability to carry cell phone off shift and respond to operational issues as required.

• Travel approximately 20% to other LIlly sites for training or support

• Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the