Senior Director, Quality

2 months ago

Pleasant Prairie, Wisconsin, United States Eli Lilly and Company Full time

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.

Organization Overview:
Lilly is expanding capability at a new state of the art Parenteral Facility in Kenosha County, Wisconsin. This is an exciting opportunity to help build upon an existing foundation to expand reach to the patients we serve. The Quality Assurance (QA) organization ensures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of the Quality Management System. QA actively participates in the commercialization and supply of medicines that help people live longer, healthier, more active lives. QA provides support of key therapeutic area strategies to increase the value of Lilly products. The Senior Director, Quality Assurance, is primarily responsible for overseeing the execution of the Quality Management System. This includes ensuring compliance with cGMPs, policies, procedures and standards that are required to support parenteral manufacturing, device assembly, and packaging. He/she will also provide quality support for achieving key business objectives. The Quality Senior Director is responsible for the productivity, tracked through metrics, and the development/enhancement of the department's staff using the performance management process. The individual in this position will be responsible for quality oversight for parenteral drug product manufacturing, as well as other Quality support functions.

Responsibilities:

The Senior Director, Quality Assurance, is responsible for providing technical understanding and communication (to various functions and organization levels) regarding the execution of the quality management system. He/she effectively influences 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. He/she leads and/or participates in the assessment, development, and implementation of critical projects in support of continuous quality improvements. This may include new facility delivery or existing facility expansion/recapitalization.

The individual in this role has supervisory responsibilities providing both administrative and technical leadership to the site. This may include serving as the Site Quality Leader for level 3 sites. The QA Sr. Director leads and manages a team including development and delivery of team objectives and individual quality system associate performance plans and objectives. He/she oversees daily work and provides direction on key priorities as needed. He/she determines and manages the work agenda and budget for the team. He/she 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 US and international regulatory requirements. The Sr. Director, Quality Assurance, ensures all required quality agreements are in place and maintained. He/she leads and responds to regulatory agency inspections and inquiries. He/she reviews/approves GMP documentation including procedures, training, master production records, technical protocols and reports, change proposals, deviations and corrective/preventive actions. This position reports to the Associate Vice President, Quality, Assurance.

Management & Organization:

Stay true to Lilly's values of Integrity, Excellence and Respect of People. Make sure employees are trained & understand "Red Book" ethics and compliance.Ensure a safe and healthy work environment. Get strong participation from the Q 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. Quality Compliance: 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 specification, 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. Participate in approving Annual Product Reviews. Ensure site audit & inspection readiness. Host audit & inspection. Assure timely closure of all regulatory commitments. Assure the adequacy & effectiveness of the site quality systems. Participate on 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).
Basic Requirements:Bachelor of Science degree or equivalent in a scientific field (e.g., chemistry, microbiology, engineering)Minimum of 10 years in the pharmaceutical industryMinimum of 10 years of leadership experience, preferably in Quality Assurance
Additional Skills/Preferences:Experience hosting regulatory agency inspectionsProficiency with computer systems including Microsoft Office productsDemonstrated technical writing abilityDemonstrated strong oral and written communicationDemonstrated ability in problem solving and critical decision-makingDemonstrated ability to coach, mentor and lead othersDemonstrated interpersonal skills with ability to influence cross-functionally and externallyDemonstrated self-motivated leadership, ensuring a fair and equitable work environmentClear understanding of cGMPs, policies, procedures, and guidelinesDemonstrated ability to maintain a safe work environment

Additional Information:Flex hours possibleMust have ability to travel (approximately 10-20%)Position requires onsite presence; this is not a remote worker role Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups. #WeAreLilly

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