Senior Director, Quality Assurance - Site Quality Leader

Lilly•Pleasant Prairie, WI

43d•Onsite

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We are looking for people who are determined to make life better for people around the world. Lilly is designing and building a Next-Generation Parenteral and Device Assembly/Packaging Facility in Kenosha County, Wisconsin. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site from the ground up. Our new Lilly Kenosha County facility will be one of Lilly’s most technically advanced manufacturing sites and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction. 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 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.

Requirements

Bachelor of Science degree or equivalent in a scientific field (e.g., pharmacy, chemistry, microbiology, engineering)
Minimum of 10 years’ experience in the pharmaceutical industry in parenteral operations
Minimum of 10 years’ leadership experience (Ideally in Quality Assurance)
Demonstrated history of hosting regulatory inspections

Nice To Haves

Demonstrated Technical writing ability
Demonstrated strong oral and written communication
Demonstrated ability in problem solving and critical decision-making
Demonstrated ability to coach, mentor and lead others
Demonstrated interpersonal skills with ability to influence cross-functionally and externally
Demonstrated self-motivated leadership, ensuring a fair and equitable work environment
Clear understanding of cGMPs, policies, procedures, and guidelines
Demonstrated ability to maintain a safe work environment

Responsibilities

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 element of the quality system, discuss the results and actions to improve Quality Management systems and execution (Management Review of Quality Systems)
Ensure that the notification/escalation process is effective, so there is appropriate resolution of quality problems. Ensure escalation of significant/critical quality problems to the appropriate levels of management following the standards set by the QMS. Cooperate with Qualify Person and the Global Quality leader in communication to Health Authorities (if applicable) ensuring timely reporting.
Participate in approving Annual Product Reviews.
Ensure site audit & inspection readiness. Host audits and inspections. Assure timely closure of all regulatory commitments.
Assure the adequacy & effectiveness of the site quality systems.
Participate in the Site Lead Team and lead the Quality Lead Team.
Ensure overall compliance with GMP regulations, Lilly Corporate Quality standards and regulatory requirements through review and approval of GMP documentation.
Ensure the site has a process to maintain compliance status through gap assessment of corporate and regulatory standards and guidelines.
Ensure adequate quality oversight on GMP documents and activities (e.g., through QA presence on the shop floor).

Benefits

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

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