Lilly Associate Director, Validation in Concord, North Carolina
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 35,000 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.
Lilly unites caring with discovery to create medicines that make life better for people around the world. Lilly is a fortune 500 company that has been in operation for over 140 years. We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People.
Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located in Concord, North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and technical organization from the ground up.
The Associate Director, Validation is responsible for staffing, training, and leadership of the Technical Services/Manufacturing Science TS/MS validation group. The specific area of responsibility includes cleaning validation, sterilization validation, filter validation, and may include the qualification of controlled temperature storage. The Associate Director may also provide input/guidance/oversight to the performance of other validation types at the site as needed. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation.
The Associate Director will be responsible for supporting the day-to-day TS/MS validation activities as well as planning for the 3-6-month horizon. The Associate Director, Validation is expected to lead by example and provide coaching to others in the areas of safety, quality, technical capability, and continuous improvement.
Key Objectives / Deliverables:
Understand the scientific principles required for manufacturing parenteral drug products, device assembly and packaging, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.
Support Site Leadership to build a diverse and capable TS/MS organization, with a focus on supporting the areas of cleaning validation, sterilization validation, filter validation, and may include qualification of controlled temperature storage.
Determine staffing and resource needs to support site TS/MS validation requirements.
Maintain metrics to measure performance against business objectives and make necessary changes to improve performance.
Provide technical guidance to the TS/MS group.
Participate in the development and implementation of strategies associated with the area sponsoring or supporting the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA).
Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections.
Manage external contracts/resources and project management resources, as needed.
Manage the development and maintenance of relevant validation program documents including SOPs and Master Plans.
Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation master plans, protocols and summary reports, etc.
Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity.
Serve as technical interface external to the Concord site.
Work within or lead cross-functional teams in positive fashion to implement TS/MS validation objectives and deliver on business plan and quality objectives.
Network and collaborate with global and other parenteral sites to understand best practices, share knowledge, and participate in tactical and strategic business planning.
Ensure a safe working environment through compliance with safety rules and improving safety culture by actively participating in safety-related activities.
Bachelors or equivalent in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or a related field
Teamwork and interpersonal skills
Technical leadership, administrative and organizational skills
Previous management or leadership experience, including leading or working effectively with a cross functional group
- Additional relevant industrial experience (greater than 5 years) in any of the following associated disciplines such as Manufacturing, Quality Control, Quality Assurance, Advanced Project Management, Development, Regulatory Sciences, or Engineering.
- Bachelors or equivalent in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or a related field
Role is Monday through Friday based.
Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.)
Occasional extended hour and / or off-hour work may be required
Position will be based out of Concord site with ability to travel to Indianapolis and other global Lilly sites as required
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 ( LillyRecruitingCompliance@lists.lilly.com ) 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.
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