Senior Director, Quality Assurance - Site Quality Leader

Role Summary

Senior Director, Quality Assurance – Site Quality Leader at Lilly's Kenosha County facility, responsible for establishing and maintaining an effective Quality Management System and ensuring compliance with cGMPs to support parenteral manufacturing, device assembly, and packaging. Leads strategic quality direction, sets site quality objectives, and guides critical quality improvement projects to meet business objectives.

Responsibilities

• The Senior Director, Quality Assurance serves as the Site Quality Leader and is primarily responsible for ensuring that an effective Quality Management System is in place. This includes ensuring compliance with cGMPs, policies, procedures and standards that are required to support parenteral manufacturing, device assembly, and packaging. They influence leadership on strategic direction and tactical implementation of the quality system, establish the site‚Äôs quality objectives, priorities, and roadmap, and lead or participate in critical projects to support continuous quality improvements and business objectives.
• The quality leader provides leadership and direction in managing product-related quality matters, assures the independence of the quality unit, makes decisions regarding quality issues, ensures products are fit for their intended use and compliant with global regulatory requirements, and leads/regulates regulatory agency inspections and inquiries.
• Stay true to Lilly‚Äôs values and ensure employees are trained and understand ethics and compliance.
• Ensure a safe and healthy work environment, drive HSE program participation, monitor and improve site goals, and ensure staff qualification and ongoing GMP education.
• Develop people capability and knowledge (technical, behavioral, managerial) and communicate quality objectives to all site personnel.
• Manage resources according to quality objectives and site priorities, including headcount and finances; recruit, coach, and develop personnel within the Lilly Quality unit.
• Ensure Quality activities are performed per procedural requirements and timelines; provide administrative support and technical leadership to the site Quality unit; ensure independence of the Site Quality Unit.
• Develop and maintain the site‚Äôs quality management system and ensure release/rejection systems for raw materials, intermediates, packaging materials, device components, and consumables.
• Establish and evaluate batch records for release in compliance with regulations and company standards; ensure controls, testing, and monitoring with quality control in accordance with marketing authorization; approve specifications, sampling instructions, test methods, and batch records; maintain quality agreements.
• Ensure site processes, equipment, instruments, utilities, and facilities are qualified/validated and maintained; implement root cause investigations for quality matters and monitor corrective actions; manage CAPA and a quality plan for improvements.
• Develop, approve, and implement Local Quality Plan and Site Quality Manual; establish governance (Quality Lead Team, Deviation Review Board, Change Control Board, CAPA board) to monitor quality indicators and drive improvements; manage notification/escalation processes with timely reporting to Health Authorities as applicable.
• Approve Annual Product Reviews; ensure audit and inspection readiness; host audits and inspections and close regulatory commitments timely; maintain overall quality system effectiveness and compliance with GMP and regulatory requirements; participate in Site Lead Team and lead the Quality Lead Team.
• Ensure GMP documentation review and approval; assess compliance status through gaps against corporate/regulatory standards; provide adequate quality oversight on GMP documents and activities (e.g., QA presence on the shop floor).

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.

Skills

• Demonstrated technical writing ability
• Strong oral and written communication
• Problem solving and critical decision-making
• Coaching, mentoring, and leadership abilities
• Interpersonal skills with ability to influence cross-functionally and externally
• Self-motivated leadership and commitment to a fair and equitable work environment
• Clear 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
• Ability to travel (approximately 10%)