Eli Lilly and Company
Associate Director - Quality Assurance
Eli Lilly and Company, Indianapolis, Indiana, us, 46262
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 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. Responsibilities
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, key internal customers/partners, and strengthen CM alliances. Establish and improve business processes to provide any necessary interface between the CM\'s and Lilly\'s quality systems (e.g., deviations, complaints, change management) via day-to-day interactions and maintaining Quality Agreements. Support API EM\'s efforts to maintain and improve our quality systems and ensure alignment with Lilly Global Quality Standards and regulatory agency expectations. Coordinate quality activities for outsourcing of Lilly\'s targeted projects to CMs, including maintaining and improving compliant oversight practices. Support regulatory agency inspections at the CM, provide management status updates and participate in the 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, rationale, and strategies to ensure harmonization and alignment between sites. Basic Qualifications
Bachelor’s Degree (Preferred: Degree in Chemistry, Biology, Biotechnology, Pharmacy, or Engineering) 5+ years experience in pharmaceutical manufacturing or development environment in any of the following associated fields: TSMS, Production, Quality Assurance, Quality Control, Engineering, or Regulatory Affairs. Additional Skills/Preferences
Responsible for 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 within the site and function 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 tasks and/or tasks that are highly cross-functional Demonstrated Project Management skills and ability to coordinate complex projects Strong analytical and quantitative problem-solving skills, with a proactive approach for identifying and addressing challenges Ability to communicate and influence effectively across functional groups and stakeholders Strategic thinking and ability to balance short term needs with long term business evolution Enthusiasm for changes, team spirit and flexibility Demonstrated ability to learn & 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 for further assistance. 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. #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 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. Responsibilities
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, key internal customers/partners, and strengthen CM alliances. Establish and improve business processes to provide any necessary interface between the CM\'s and Lilly\'s quality systems (e.g., deviations, complaints, change management) via day-to-day interactions and maintaining Quality Agreements. Support API EM\'s efforts to maintain and improve our quality systems and ensure alignment with Lilly Global Quality Standards and regulatory agency expectations. Coordinate quality activities for outsourcing of Lilly\'s targeted projects to CMs, including maintaining and improving compliant oversight practices. Support regulatory agency inspections at the CM, provide management status updates and participate in the 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, rationale, and strategies to ensure harmonization and alignment between sites. Basic Qualifications
Bachelor’s Degree (Preferred: Degree in Chemistry, Biology, Biotechnology, Pharmacy, or Engineering) 5+ years experience in pharmaceutical manufacturing or development environment in any of the following associated fields: TSMS, Production, Quality Assurance, Quality Control, Engineering, or Regulatory Affairs. Additional Skills/Preferences
Responsible for 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 within the site and function 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 tasks and/or tasks that are highly cross-functional Demonstrated Project Management skills and ability to coordinate complex projects Strong analytical and quantitative problem-solving skills, with a proactive approach for identifying and addressing challenges Ability to communicate and influence effectively across functional groups and stakeholders Strategic thinking and ability to balance short term needs with long term business evolution Enthusiasm for changes, team spirit and flexibility Demonstrated ability to learn & 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 for further assistance. 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. #WeAreLilly
#J-18808-Ljbffr