Sr. Director – Quality Control Laboratories - Eli Lilly and Company
Indianapolis, IN 46201
About the Job
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.Lilly is currently expanding its global manufacturing footprint and is looking for experienced QC Microbiology Laboratory leaders to provide leadership for a team of experienced microbiological scientist who oversee testing related to manufacturing operations in Indiana.The Sr. Director – QC Quality Control Microbiological Laboratory provides administrative leadership for the Microbiological Quality Control laboratories and ensure appropriate capabilities and business processes are developed and maintained in a manufacturing site. This position involves working cross functionally within the site and across the network to develop the strategic functional capabilities needed to support the mission of the site. Responsibilities of this role include but are not limited to the following:- Responsible for the oversight of environmental monitoring sampling operations, environmental monitoring laboratories, FUME (utilities monitoring), and the environmental monitoring batch release process (EMER), supporting Parenteral Operations. This includes coordinating sampling logistics and scheduling; sample and data handling and processing; investigation of potential contamination issues; and data evaluation. The role is also responsible for Environmental Monitoring Performance Qualifications.- Responsible for the oversight and execution of microbiological product testing, including tests for raw materials, in-process samples, semi-finished and finished products.The individual in this role must have expertise in QC microbiological operations and quality systems and a demonstrated ability to develop and lead large teams, lead leaders within an organization, and influence across networks and with global organizations.Responsibilities:Business Support
• Maintain a safe work environment that complies with regulations, lead safety initiatives within the Quality Labs and across the Site.
• Ensure a high-quality organization in support of Quality Laboratory Operations
• Maintain GMP Compliance in all Laboratory Operations
• Implement the lab of the future vision including integrated digital, paperless processes.
• Participate on the local area lead teams and Quality Lead Team.
• Works closely with Global Quality Analytical Sciences and QC Operations team to ensure consistent and standardized approaches to laboratory organizational design, business processes, and systems.
• Implement and sustain Lean Operational Excellence principles
• Exhibit critical business decision bringing about successful results.
• Communicate to and strive for integration of support groups outside plant.
• Coordinate laboratory related business planning and budget management.
• Network internally and externally to understand best practices, share knowledge, participate in tactical and strategic business planning, and to ensure customer needs are met.
• Network with other sites regarding new systems development and standardization of processesCompliance Oversight
• Ensure CGMP quality and compliance deliverables are met across laboratories and a robust inspection readiness program is in place.
• Ensure inspection readiness and inspection readiness programs.
• Coordinate and manage all regulatory and internal inspections.Personnel Development
• Participate in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports.
• Ensure Human Resource Processes are established and maintained across the QCL organization.
• Recruit new talent and develop site capabilities to deliver a high functioning QCL organization.
• Ensure administrative and technical capability within the organization.Basic Requirements:
• Bachelor’s degree in microbiology, chemistry, or related discipline
• Minimum of 10 years supporting microbiological and sterility testing
• 10 years of leadership experienceAdditional Skills/Preferences:
• Knowledge of QC operations, new product Introduction and process development support
• Expertise in CGMP quality and compliance requirements for QC laboratories, including expertise in regulatory requirements
• Experience with regulatory submissions
• Proficiency with computer systems including Microsoft Office products.
• Demonstrated technical writing ability.
• Demonstrated strong oral and written communication.
• Demonstrated interpersonal skills with ability to lead leaders and influence cross-functionally and externally.
• Demonstrated ability to maintain a safe work environment.Additional Information:
• Flex hours possible
• Primary location is Indiana
• Ability to travel (approximately 10%)Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form () for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.#WeAreLillySummaryLocation: US, Indianapolis INType:
• Maintain a safe work environment that complies with regulations, lead safety initiatives within the Quality Labs and across the Site.
• Ensure a high-quality organization in support of Quality Laboratory Operations
• Maintain GMP Compliance in all Laboratory Operations
• Implement the lab of the future vision including integrated digital, paperless processes.
• Participate on the local area lead teams and Quality Lead Team.
• Works closely with Global Quality Analytical Sciences and QC Operations team to ensure consistent and standardized approaches to laboratory organizational design, business processes, and systems.
• Implement and sustain Lean Operational Excellence principles
• Exhibit critical business decision bringing about successful results.
• Communicate to and strive for integration of support groups outside plant.
• Coordinate laboratory related business planning and budget management.
• Network internally and externally to understand best practices, share knowledge, participate in tactical and strategic business planning, and to ensure customer needs are met.
• Network with other sites regarding new systems development and standardization of processesCompliance Oversight
• Ensure CGMP quality and compliance deliverables are met across laboratories and a robust inspection readiness program is in place.
• Ensure inspection readiness and inspection readiness programs.
• Coordinate and manage all regulatory and internal inspections.Personnel Development
• Participate in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports.
• Ensure Human Resource Processes are established and maintained across the QCL organization.
• Recruit new talent and develop site capabilities to deliver a high functioning QCL organization.
• Ensure administrative and technical capability within the organization.Basic Requirements:
• Bachelor’s degree in microbiology, chemistry, or related discipline
• Minimum of 10 years supporting microbiological and sterility testing
• 10 years of leadership experienceAdditional Skills/Preferences:
• Knowledge of QC operations, new product Introduction and process development support
• Expertise in CGMP quality and compliance requirements for QC laboratories, including expertise in regulatory requirements
• Experience with regulatory submissions
• Proficiency with computer systems including Microsoft Office products.
• Demonstrated technical writing ability.
• Demonstrated strong oral and written communication.
• Demonstrated interpersonal skills with ability to lead leaders and influence cross-functionally and externally.
• Demonstrated ability to maintain a safe work environment.Additional Information:
• Flex hours possible
• Primary location is Indiana
• Ability to travel (approximately 10%)Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form () for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.#WeAreLillySummaryLocation: US, Indianapolis INType:
Source : Eli Lilly and Company