Sr. Director-Quality

Overview

Lilly is designing and building a Next-Generation Parenteral and Device Assembly/Packaging Facility in Research Triangle Park, NC. This is an exciting opportunity to help build and operate 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. They effectively influence the leadership on strategic direction and tactical implementation of the quality system.

The individual in this role establishes the site´s quality objectives, priorities, and roadmap. The senior director leads and/or participates in the assessment, development, and implementation of critical projects in support of continuous quality improvements. He/she will also provide quality support for achieving key business objectives. 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 and comply with global regulatory requirements. The Site Quality Leader 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 to HSE program.
• Monitor, verify, evaluate, and drive improvement towards site goals.
• Ensure staff is qualified, 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.
• Assures the independence of the Site Quality Unit.
• Ensures the development, adequacy, and effectiveness of the site’s quality management system.
• Ensures 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 & facilities are qualified/validated and maintained for the intended use.
• Ensure that there is a process at the site to perform root cause investigation for quality matters (deviations, complaints, stability failures, results out specification) and there is a system for monitoring of corrective actions.
• Ensure there is a process for evaluating proposed changes.
• Ensure the site has a CAPA program and a quality plan where corrections and corrective actions and significant quality improvement/enhancement initiatives are described.
• Ensure development, approval and implementation of Local Quality Plan and Site Quality Manual.
• Ensure that a process of governance and control is in place (Quality Lead Team, established Deviation Review Board, Change Control Board, CAPA board) to ensure monitoring of quality indicators applied to each…