Sr. Director - API Manufacturing Quality Assurance
BioSpace, Inc.
- United States
- United States
À propos
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Sr. Director - API Manufacturing Quality Assurance
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BioSpace . 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 worldwide 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. Were looking for people who are determined to make life better for people around the world. Lilly is currently constructing an advanced manufacturing facility for the 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 a 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. 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
Bachelors 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
Compensation
Actual compensation will depend on a candidates education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $222,200. Benefits
Full?time employees are eligible for a comprehensive benefit program, including eligibility to participate in a company?sponsored 401(k), pension; vacation benefits; medical, dental, vision, and prescription drug benefits; flexible benefits such as healthcare and/or dependent day?care flexible spending accounts; life insurance and death benefits; certain time off and leave of absence benefits; and well?being benefits (employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion. Equal Employment Opportunity
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. Accommodations
Lilly is dedicated to helping individuals with disabilities actively engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. #J-18808-Ljbffr
Compétences linguistiques
- English
Avis aux utilisateurs
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