Sr. Manager - Quality Assurance

Role Summary

Sr. Manager, Quality Assurance at Lilly, responsible for leadership and technical oversight of formulation, filling, and visual inspection operations to ensure regulatory compliance and quality. Combines people management with QA expertise to drive continuous improvement, operational readiness, and a strong quality culture at the RTP state-of-the-art facility.

Responsibilities

• Build and manage a functional QA organization that supports operational excellence, lean practices, and shopfloor presence.
• Lead, mentor, and coach QA floor teams, fostering a culture of safety, quality, compliance, and continuous improvement.
• Establish and monitor performance objectives, providing feedback and coaching to drive team development.
• Identify business and quality risks, escalating appropriately and in a timely manner.
• Provide continuous quality improvement oversight to regulated processes, practices, and documentation.
• Review and approve GMP documentation, including procedures, deviations, technical reports, and change controls to ensure compliance with Lilly Global Quality Standards and regulatory requirements.
• Network with global and parenteral sites to share best practices, improve processes and resolve product-related issues.
• Work cross-functionally with process teams for metrics reviews, operational support, and deviation management.
• Provide guidance and share technical knowledge in operational areas to ensure robust Quality Systems and GMP compliance.
• Participate in inspections from regulatory agencies and corporate audits, and manage responses to findings.
• Ensure compliance with corporate, local, and regulatory agency policies, procedures, and guidelines.
• Provide QA oversight of formulation, filling operations using isolator technology, and visual inspection processes.
• Lead or participate in non-routine investigations, root cause analysis, and corrective/preventive actions.

Qualifications

• Required: Bachelor‚Äôs or Master‚Äôs degree in Engineering, Life Sciences, or related field.
• Required: 7+ years of experience in Quality Assurance, with at least 3 years in a leadership role.
• Required: Demonstrated strong experience with pharmaceutical manufacturing and working knowledge of Quality Management Systems and regulatory requirements.
• Required: Attention to detail and ability to maintain quality systems.
• Required: Experience leading or collaborating with cross-functional teams.
• Required: Excellent interpersonal, written and oral communication skills.
• Required: Strong technical aptitude and ability to train and mentor others.
• Required: Decision making and problem-solving skills; ability to organize and prioritize multiple tasks.
• Preferred: Experience with highly automated parenteral manufacturing processes, isolators, automated inspection.
• Preferred: Experience with Manufacturing Execution Systems and electronic batch release.
• Preferred: CQM, CQE, or CQA certification from ASQ.
• Preferred: Experience with Trackwise, Veeva, MODA.

Education

• Bachelor‚Äôs or Master‚Äôs degree in Engineering, Life Sciences, or related field.

Additional Requirements

• The normal schedule is Monday-Friday, 8 hours/day, with possible non-standard hours for floor QA support and planned shutdowns.
• Support for 24/7 manufacturing operations.