Eli Lilly and Company
Sr. Director - API Manufacturing Quality Assurance
Eli Lilly and Company, Richmond, Virginia, United States, 23214
Overview
Sr. Director – API Manufacturing Quality Assurance serves as the Site Quality Leader for the Lilly API site, overseeing manufacturing, utilities, laboratories, and warehousing. This role ensures the strength and continuous improvement of all quality and compliance systems, activities, and personnel. The Sr. Director – QA is responsible for maintaining utilities and ensuring that raw materials and drug substances are produced and released in accordance with cGMP standards and marketing authorization requirements. Key Responsibilities
Serve as Site Quality Leader on the Lilly Site Lead Team. Ensure site-wide compliance with cGMPs, procedures, standards, and regulatory commitments. Lead the API Quality Team and manage its agenda. Support quality forums (e.g., Deviation and Change Control Boards). Develop and monitor a site Quality Plan and metrics. Coordinate and manage regulatory inspections. Review and approve manufacturing and quality system documents. Ensure adequate QA staffing and provide coaching and development. Use HR tools for performance management, staffing, and succession planning. Contribute to QA business planning and site-wide strategic planning. Basic Requirements
Bachelor's degree (STEM degree preferred) 10+ years of pharmaceutical manufacturing quality experience 5+ years of supervision/leadership experience Additional Preferences
Experience in Manufacturing, Development, QC, Technical Services, Engineering, or Regulatory Affairs Proficient in statistical analysis and computer applications Strong interpersonal, communication, and networking skills Ability to influence diverse teams and manage multiple priorities Demonstrated problem-solving and analytical thinking Equal Opportunity and Accommodation
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. This is for individuals to request an accommodation as part of the application process; other correspondence will not receive a response. 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. Compensation and Benefits
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $222,200 . Full-time employees are eligible for a company bonus (dependent on company and individual performance). Lilly offers a comprehensive benefit program to eligible employees, including 401(k); pension; vacation benefits; medical, dental, vision, and prescription drug benefits; flexible benefits; life insurance and death benefits; leave of absence benefits; and well-being benefits. #WeAreLilly
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Sr. Director – API Manufacturing Quality Assurance serves as the Site Quality Leader for the Lilly API site, overseeing manufacturing, utilities, laboratories, and warehousing. This role ensures the strength and continuous improvement of all quality and compliance systems, activities, and personnel. The Sr. Director – QA is responsible for maintaining utilities and ensuring that raw materials and drug substances are produced and released in accordance with cGMP standards and marketing authorization requirements. Key Responsibilities
Serve as Site Quality Leader on the Lilly Site Lead Team. Ensure site-wide compliance with cGMPs, procedures, standards, and regulatory commitments. Lead the API Quality Team and manage its agenda. Support quality forums (e.g., Deviation and Change Control Boards). Develop and monitor a site Quality Plan and metrics. Coordinate and manage regulatory inspections. Review and approve manufacturing and quality system documents. Ensure adequate QA staffing and provide coaching and development. Use HR tools for performance management, staffing, and succession planning. Contribute to QA business planning and site-wide strategic planning. Basic Requirements
Bachelor's degree (STEM degree preferred) 10+ years of pharmaceutical manufacturing quality experience 5+ years of supervision/leadership experience Additional Preferences
Experience in Manufacturing, Development, QC, Technical Services, Engineering, or Regulatory Affairs Proficient in statistical analysis and computer applications Strong interpersonal, communication, and networking skills Ability to influence diverse teams and manage multiple priorities Demonstrated problem-solving and analytical thinking Equal Opportunity and Accommodation
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. This is for individuals to request an accommodation as part of the application process; other correspondence will not receive a response. 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. Compensation and Benefits
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $222,200 . Full-time employees are eligible for a company bonus (dependent on company and individual performance). Lilly offers a comprehensive benefit program to eligible employees, including 401(k); pension; vacation benefits; medical, dental, vision, and prescription drug benefits; flexible benefits; life insurance and death benefits; leave of absence benefits; and well-being benefits. #WeAreLilly
#J-18808-Ljbffr