Eli Lilly and Company
Associate Director - Quality Assurance
Eli Lilly and Company, Pleasant Prairie, Wisconsin, United States, 53158
Overview
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 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 put people first and strive to make life better for people around the world. Responsibilities
Associate Director – Quality Assurance (QA) API External Manufacturing is responsible for managing the activities of QA personnel supporting the oversight of externally manufactured Peptides and Intermediates. Balance coaching the QA staff, prioritization and staffing for routine production support activities, implementation of Quality projects, technology transfers, and commercialization. Oversee quality projects supporting API EM, productivity and development of QA employees, and the quality of the API EM Tides portfolio of products manufactured by Contract Manufacturers (CM). Ensure the CM quality systems meet cGMPs and are compliant with Quality Agreements. Oversee department performance, resolution of quality issues, and overarching compliance. Work cross-functionally within the site, network, commercialization teams, and multiple global suppliers to deliver on business plans and quality objectives. Make decisions regarding the quality of batches, resolution of quality issues and quality performance for partners. Lead the API EM QA team, providing coaching/feedback to develop QA employees, including performance management, talent assessments, mentoring, succession planning, and organizational planning. Build working relationships with API EM management, internal customers/partners, and CM alliances. Establish and improve business processes interfacing between CM quality systems and Lilly's quality systems (deviations, complaints, change management) via day-to-day interactions and maintaining Quality Agreements. Support API EM quality systems to align with Lilly Global Quality Standards and regulatory expectations. Coordinate quality activities for outsourcing of Lilly's targeted projects to CMs, maintaining and improving compliant oversight practices. Support regulatory agency inspections at the CM, provide management status updates, and participate in resolution of regulatory findings by coordinating CM and Lilly responses. Ensure adequate oversight and excellence for investigations and complaints. Network globally to share best practices to harmonize and align between sites. Basic Qualifications
Required: Bachelor’s Degree (preferred: Chemistry, Biology, Biotechnology, Pharmacy, or Engineering) Minimum of five years experience in pharmaceutical manufacturing or development environment in areas such as TSMS, Production, Quality Assurance, Quality Control, Engineering, or Regulatory Affairs. Additional Skills/Preferences
Maintaining a safe work environment Proven leadership, administrative and organizational skills In-depth knowledge of cGMPs and regulatory expectations Ability to influence and lead diverse groups Influences complex regulatory, business, or technical issues High attention to detail and a commitment to quality and compliance Builds relationships with internal and external customers and partners Proficiency in delivering highly complex, cross-functional tasks Demonstrated project management skills for coordinating complex projects Strong analytical and problem-solving skills with a proactive approach Ability to communicate and influence effectively across functional groups Strategic thinking balancing short-term needs with long-term evolution Enthusiasm for change, team spirit, and flexibility Ability to learn and apply technical/scientific knowledge Additional Information
10 – 20% travel may be required Some off-shift work (night/weekend) may be required to support 24/7 operations across global supplier network 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 at https://careers.lilly.com/us/en/workplace-accommodation for further assistance. This is for individuals to request an accommodation as part of the application process. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $118,500 - $173,800. Full-time employees are eligible for a company bonus and a comprehensive benefits program including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; medical, dental, vision and prescription drug benefits; flexible benefits; life insurance and other benefits. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs as needed. #WeAreLilly
#J-18808-Ljbffr
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 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 put people first and strive to make life better for people around the world. Responsibilities
Associate Director – Quality Assurance (QA) API External Manufacturing is responsible for managing the activities of QA personnel supporting the oversight of externally manufactured Peptides and Intermediates. Balance coaching the QA staff, prioritization and staffing for routine production support activities, implementation of Quality projects, technology transfers, and commercialization. Oversee quality projects supporting API EM, productivity and development of QA employees, and the quality of the API EM Tides portfolio of products manufactured by Contract Manufacturers (CM). Ensure the CM quality systems meet cGMPs and are compliant with Quality Agreements. Oversee department performance, resolution of quality issues, and overarching compliance. Work cross-functionally within the site, network, commercialization teams, and multiple global suppliers to deliver on business plans and quality objectives. Make decisions regarding the quality of batches, resolution of quality issues and quality performance for partners. Lead the API EM QA team, providing coaching/feedback to develop QA employees, including performance management, talent assessments, mentoring, succession planning, and organizational planning. Build working relationships with API EM management, internal customers/partners, and CM alliances. Establish and improve business processes interfacing between CM quality systems and Lilly's quality systems (deviations, complaints, change management) via day-to-day interactions and maintaining Quality Agreements. Support API EM quality systems to align with Lilly Global Quality Standards and regulatory expectations. Coordinate quality activities for outsourcing of Lilly's targeted projects to CMs, maintaining and improving compliant oversight practices. Support regulatory agency inspections at the CM, provide management status updates, and participate in resolution of regulatory findings by coordinating CM and Lilly responses. Ensure adequate oversight and excellence for investigations and complaints. Network globally to share best practices to harmonize and align between sites. Basic Qualifications
Required: Bachelor’s Degree (preferred: Chemistry, Biology, Biotechnology, Pharmacy, or Engineering) Minimum of five years experience in pharmaceutical manufacturing or development environment in areas such as TSMS, Production, Quality Assurance, Quality Control, Engineering, or Regulatory Affairs. Additional Skills/Preferences
Maintaining a safe work environment Proven leadership, administrative and organizational skills In-depth knowledge of cGMPs and regulatory expectations Ability to influence and lead diverse groups Influences complex regulatory, business, or technical issues High attention to detail and a commitment to quality and compliance Builds relationships with internal and external customers and partners Proficiency in delivering highly complex, cross-functional tasks Demonstrated project management skills for coordinating complex projects Strong analytical and problem-solving skills with a proactive approach Ability to communicate and influence effectively across functional groups Strategic thinking balancing short-term needs with long-term evolution Enthusiasm for change, team spirit, and flexibility Ability to learn and apply technical/scientific knowledge Additional Information
10 – 20% travel may be required Some off-shift work (night/weekend) may be required to support 24/7 operations across global supplier network 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 at https://careers.lilly.com/us/en/workplace-accommodation for further assistance. This is for individuals to request an accommodation as part of the application process. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $118,500 - $173,800. Full-time employees are eligible for a company bonus and a comprehensive benefits program including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; medical, dental, vision and prescription drug benefits; flexible benefits; life insurance and other benefits. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs as needed. #WeAreLilly
#J-18808-Ljbffr