Sr. Director - Quality, Concord

Responsibilities

The Site Quality Leader is primarily responsible for overseeing the execution of the Quality Management System, ensuring compliance with cGMPs, corporate quality standards and regulatory requirements for parenteral manufacturing, device assembly and packaging. The role establishes the site’s quality objectives, priorities and roadmap, leads critical projects, provides quality support for business objectives and ensures product fitness and regulatory compliance.

• Ensure compliance with cGMPs, corporate quality standards and regulatory requirements for parenteral drug product manufacturing, device assembly and packaging.
• Develop and implement the site’s quality objectives, priorities and roadmap.
• Lead and participate in assessment, development and implementation of critical projects for continuous quality improvements.
• Provide quality support to achieve key business objectives and oversee quality-related activities.
• Review, approve GMP documentation including procedures, training, master production records, technical protocols, reports, change proposals, deviations, and corrective/preventive actions.
• Manage quality oversight and independence of the quality unit, ensuring timely resolution of quality issues.
• Ensure a safe and healthy work environment, including HSE program participation.
• Maintain and improve communication of quality objectives and priorities to all site personnel.
• Recruit, coach and develop personnel within the Lilly quality unit and perform performance management.
• Ensure proper qualification/validation of site processes, equipment, instruments, utilities and facilities.
• Establish and maintain a CAPA program, root cause investigation process and quality plan.
• Prepare for and lead regulatory agency inspections and inquiries, including annual product reviews and site audit readiness.
• Participate on the Site Lead Team, lead the Quality Lead Team, and manage governance and control processes.
• Advise on and monitor compliance status through gap assessment of corporate and regulatory standards.

Annual salary range: $172,500 - $253,000. Full‑time employees eligible for company bonus, based on company and individual performance. Additionally, Lilly offers a comprehensive benefit program including 401(k) match, pension, paid vacation, medical, dental, vision, prescription drug, flexible benefits, life insurance, death benefits, leave of absence, employee assistance program, fitness benefits and employee clubs.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Lilly also offers accommodation for individuals with disabilities through a workplace accommodation request form.