Senior Director, Quality Assurance - Site Quality Leader

Role Summary

The Senior Director, Quality Assurance – Site Quality Leader is responsible for ensuring an effective Quality Management System is in place to support parenteral manufacturing, device assembly, and packaging. This role leads the site quality function, setting quality objectives, priorities, and a roadmap, and drives continuous quality improvements, regulatory readiness, and alignment with global regulatory requirements.

Responsibilities

• Lead and/or participate in assessment, development, and implementation of critical projects to support continuous quality improvements.
• Provide quality support for achieving key business objectives; influence leadership on strategic direction and tactical implementation of the quality system.
• Ensure compliance with cGMPs, policies, procedures and standards; manage product-related quality matters and maintain independence of the quality unit.
• Lead regulatory inspections and inquiries and maintain site audit/inspections readiness.
• Develop quality objectives and priorities, communicate them to all site personnel, and manage resources including headcount and finances.
• Recruit, coach, and develop personnel within the Lilly Quality unit; ensure staff are qualified and trained in GMP education as needed.
• Ensure quality activities are performed per procedural requirements and within planned timelines; provide administrative and technical leadership to the site Quality unit.
• Oversee release/rejection of materials, batch record evaluations, specifications, sampling, test methods, and batch records in accordance with regulations and company standards.
• Maintain quality agreements; ensure site processes, equipment, utilities, and facilities are qualified and maintained for intended use; govern CAPA, quality plans, and proposed changes.
• Establish governance for quality indicators (Quality Lead Team, Deviation Review Board, Change Control Board, CAPA board); monitor results and drive improvements.
• Escalate significant quality problems to appropriate management levels and coordinate with Health Authorities as applicable.
• Participate in Annual Product Reviews; oversee site audits/inspections and timely closure of regulatory commitments.
• Ensure GMP documentation is reviewed and approved; assess compliance status against corporate and regulatory standards; maintain GMP oversight on shop floor activities.

Qualifications

• Required: Bachelor of Science degree or equivalent in a scientific field (e.g., pharmacy, chemistry, microbiology, engineering).
• Required: Minimum of 10 years‚Äô experience in the pharmaceutical industry in parenteral operations.
• Required: Minimum of 10 years‚Äô leadership experience (ideally in Quality Assurance).
• Required: Demonstrated history of hosting regulatory inspections.
• Preferred: Demonstrated Technical writing ability; strong oral and written communication; problem solving and critical decision-making; coaching and leadership; cross-functional influence; understanding of cGMPs and regulatory guidelines; ability to maintain a safe work environment.

Skills

• Technical writing
• Oral and written communication
• Problem solving and decision-making
• Coaching, mentoring, and leadership
• Cross-functional collaboration and influence
• Leadership with a focus on fairness and equity
• Deep understanding of cGMPs, policies, procedures, and guidelines
• Ability to maintain a safe work environment

Education

• Bachelor of Science degree or equivalent in a scientific field (e.g., pharmacy, chemistry, microbiology, engineering)

Additional Requirements

• On-site presence required
• Flex hours possible
• Travel ability approximately 10%