BioSpace
Sr. Director - API Manufacturing Quality Assurance
BioSpace, Houston, Texas, United States, 77246
Sr. Director - API Manufacturing Quality Assurance
Base pay range: $151,500.00/yr - $222,200.00/yr 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 seek individuals determined to make life better for people around the world. Lilly is currently constructing an advanced manufacturing facility for production of API molecules. This facility is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations. Position Overview The Sr. Director – QA 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. Additionally, 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 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. Any 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. Our employee resource groups (ERGs) offer strong support networks and are open to all employees, including groups such as Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. 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 (subject to company and individual performance). Lilly offers 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; leave of absence benefits; and well-being programs. #WeAreLilly Seniority level Director Employment type Full-time Job function Management and Manufacturing Industries Healthcare Referrals increase your chances of interviewing at Lilly. This description also references related roles; for example, Senior Director, Technical Manufacturing in Houston, TX and other API manufacturing positions.
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Base pay range: $151,500.00/yr - $222,200.00/yr 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 seek individuals determined to make life better for people around the world. Lilly is currently constructing an advanced manufacturing facility for production of API molecules. This facility is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations. Position Overview The Sr. Director – QA 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. Additionally, 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 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. Any 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. Our employee resource groups (ERGs) offer strong support networks and are open to all employees, including groups such as Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. 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 (subject to company and individual performance). Lilly offers 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; leave of absence benefits; and well-being programs. #WeAreLilly Seniority level Director Employment type Full-time Job function Management and Manufacturing Industries Healthcare Referrals increase your chances of interviewing at Lilly. This description also references related roles; for example, Senior Director, Technical Manufacturing in Houston, TX and other API manufacturing positions.
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