Sr. Director-Quality

We are building a Next-Generation Parenteral and Device Assembly/Packaging Facility in Research Triangle Park, NC. This opportunity supports the establishment and operation of a state‑of‑the‑art manufacturing site from the ground up.

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. The Senior Director provides strategic direction and tactical implementation of the quality system, establishes the site’s quality objectives, priorities, and roadmap, and leads the assessment, development, and implementation of critical projects supporting continuous quality improvements.

The quality leader provides leadership and direction in managing product- related quality matters, assuring the independence of the quality unit while making decisions regarding quality issues. This individual ensures that the products are fit for their intended use, comply with global regulatory requirements, and leads and responds to regulatory agency inspections and inquiries.

• Stay true to Lilly’s values of Integrity, Excellence and Respect for People. Make sure employees are trained & understand "Red Book" ethics and compliance.
• Ensure a safe and healthy work environment. Get strong participation from the Quality team in the HSE program and monitor, verify, evaluate, and drive improvement toward site goals.
• Ensure staff is qualified and that the initial & continuous training/GMP education of all personnel is carried out as needed.
• Develop people capability & knowledge (technical expertise, behavioral & managerial).
• Ensure communication of the quality objectives and priorities to all site personnel.
• Manage resources according to quality objectives, site priorities & anticipate future business needs including headcount and finances.
• Actively recruit, coach, and develop personnel within the Lilly Quality unit.
• Ensure that Quality activities are performed in accordance with procedural requirements and meet planned timelines.
• Provide administrative support & technical leadership to the site Quality unit.
• Assure the independence of the Site Quality Unit.
• Ensure the development, adequacy, and effectiveness of the site’s quality management system.
• Ensure systems are in place to release or reject raw materials, intermediates, packaging materials, device components, and consumables.
• Establish and ensure a system is in place for evaluating and releasing batch records in accordance with regulations and company standards.
• Ensure all necessary controls, testing, and monitoring are carried out with the quality control function in accordance with the marketing authorization.
• Ensure a system is in place for approving specifications, sampling instructions, test methods & batch records.
• Ensure that all required quality agreements are in place & maintained.
• Ensure site processes, equipment, instruments, utilities