Eli Lilly
Associate Director - QA Parenteral
Eli Lilly, Denver, North Carolina, United States, 28037
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.
Associate Director Quality Assurance (QA) Parenteral is responsible for the staffing, training, and leadership of the quality assurance group supporting the project/expansion delivery, process development, operational readiness, start up, and validation/qualification of the parenteral process including dispensing, equipment preparation, formulation, filling and visual inspection. The Associate Director will help build a strong quality culture and lead the QA team for oversight and support of the ongoing operation as well as site inspection readiness and execution.
Responsibilities:
Supporting the site to ensure a safe work environment including supporting and leading safety efforts for teamBuild a diverse and capable site organization to support quality oversight, and ensure compliance with area procedures and controls for parenteral operationsFoster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work groupDemonstrated administrative leadership of a diverse team including performance management and personnel development.Ability to utilize team through active engagement and delegation to achieve results through others and deliver according to plan.Ability to manage multiple priorities in a fast-paced environment and deliver in accordance with established due dates.Ability to demonstrate flexibility with quick response as priorities change or issues arise.Support the development of the overall site operational readiness plan including establishment and reinforcement of quality processes and approval of operational proceduresWork cross-functionally with the area process teams/flow team for metrics reviews, operational support, and issue / deviation managementReview and approve GMP documentation including qualification/validation protocols and reports, procedures, deviations, technical reports, change controls, etc.Partner with production and design organization to ensure 24/7 Quality oversight and supportEngage and support Operational Excellence initiatives for monitoring performance and continuously improving the operationNetwork with global and other parenteral network sites to understand best practices, share knowledge, and participate in tactical and strategic business planningSupport the Site Quality Leader in the development of the site organization, creation of the Quality Management System implementation plan, and execution of site quality operations in parenteral productionActive communication on project and production status.Define, lead and/or support inspection readiness activities for operations and interact with Regulatory agencies during inspectionsBasic Requirements:
Bachelor's degree in a science, engineering, computer, pharmaceutical related field of study or equivalent experience.7+ years of experience in a Quality role supporting pharmaceutical/medical device manufacturing.Additional Skills/Preferences:
Experience working in the pharmaceutical industry in QA/QC rolesPrevious experience in parenteral production supportPrevious management or leadership experience including leading or working effectively with a cross functional groupStrong knowledge of Quality Management Systems and applicable regulatory requirementsPrevious experience directly supporting a pharmaceutical manufacturing operationExcellent interpersonal, written, and oral communication skillsStrong technical aptitude and ability to train and mentor othersPrevious facility or area start up experiencePrevious equipment qualification and process validation experiencePrevious experience with SAP or other inventory management systemsPrevious experience with highly automated parenteral manufacturing processes including isolators, automated inspection, etc.Previous experience with Manufacturing Execution Systems and electronic batch releaseCQM, CQE, or CQA certification from the American Society for Quality (ASQ)Previous experience with deviation and change management systems including TrackwiseAdditional Information:
Ability to work 8-hour days - Monday through FridayAbility to work overtime as requiredAbility to travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations
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 (https://careers.lilly.com/us/en/workplace-accommodation) 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.
#WeAreLilly
Associate Director Quality Assurance (QA) Parenteral is responsible for the staffing, training, and leadership of the quality assurance group supporting the project/expansion delivery, process development, operational readiness, start up, and validation/qualification of the parenteral process including dispensing, equipment preparation, formulation, filling and visual inspection. The Associate Director will help build a strong quality culture and lead the QA team for oversight and support of the ongoing operation as well as site inspection readiness and execution.
Responsibilities:
Supporting the site to ensure a safe work environment including supporting and leading safety efforts for teamBuild a diverse and capable site organization to support quality oversight, and ensure compliance with area procedures and controls for parenteral operationsFoster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work groupDemonstrated administrative leadership of a diverse team including performance management and personnel development.Ability to utilize team through active engagement and delegation to achieve results through others and deliver according to plan.Ability to manage multiple priorities in a fast-paced environment and deliver in accordance with established due dates.Ability to demonstrate flexibility with quick response as priorities change or issues arise.Support the development of the overall site operational readiness plan including establishment and reinforcement of quality processes and approval of operational proceduresWork cross-functionally with the area process teams/flow team for metrics reviews, operational support, and issue / deviation managementReview and approve GMP documentation including qualification/validation protocols and reports, procedures, deviations, technical reports, change controls, etc.Partner with production and design organization to ensure 24/7 Quality oversight and supportEngage and support Operational Excellence initiatives for monitoring performance and continuously improving the operationNetwork with global and other parenteral network sites to understand best practices, share knowledge, and participate in tactical and strategic business planningSupport the Site Quality Leader in the development of the site organization, creation of the Quality Management System implementation plan, and execution of site quality operations in parenteral productionActive communication on project and production status.Define, lead and/or support inspection readiness activities for operations and interact with Regulatory agencies during inspectionsBasic Requirements:
Bachelor's degree in a science, engineering, computer, pharmaceutical related field of study or equivalent experience.7+ years of experience in a Quality role supporting pharmaceutical/medical device manufacturing.Additional Skills/Preferences:
Experience working in the pharmaceutical industry in QA/QC rolesPrevious experience in parenteral production supportPrevious management or leadership experience including leading or working effectively with a cross functional groupStrong knowledge of Quality Management Systems and applicable regulatory requirementsPrevious experience directly supporting a pharmaceutical manufacturing operationExcellent interpersonal, written, and oral communication skillsStrong technical aptitude and ability to train and mentor othersPrevious facility or area start up experiencePrevious equipment qualification and process validation experiencePrevious experience with SAP or other inventory management systemsPrevious experience with highly automated parenteral manufacturing processes including isolators, automated inspection, etc.Previous experience with Manufacturing Execution Systems and electronic batch releaseCQM, CQE, or CQA certification from the American Society for Quality (ASQ)Previous experience with deviation and change management systems including TrackwiseAdditional Information:
Ability to work 8-hour days - Monday through FridayAbility to work overtime as requiredAbility to travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations
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 (https://careers.lilly.com/us/en/workplace-accommodation) 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.
#WeAreLilly