Senior Director Quality Control
Eli Lilly and Company
4 hours ago
On-site
Lebanon, IN
$151,500 - $222,200 USD yearly
Operations
Senior Director – Quality Control (LP1, Lilly Lebanon API)
Main Purpose and Objectives
- Provide administrative and technical leadership for the development, performance, and maintenance of QC Labs during start-up, implementation, and day-to-day operations.
- Balance coaching/leadership of a technical staff with prioritization/staffing for routine production support, implementation of technical projects, and process optimizations.
- Ensure knowledge and application of cGMPs, global regulatory manufacturing guidance, and validation standards; partner cross-functionally to deliver technical objectives, product business plan objectives, and quality objectives.
Key Responsibilities
- Provide technical leadership; performance management, training, and development of staff.
- Maintain a safe work environment.
- Ensure GMP compliance.
- Ensure technical review and approval for documents including: investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, and technical studies.
- Partner within Quality Control and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
- Interact with regulators, customers, and other stakeholders; support internal and external agency audits.
- Provide oversight and technical excellence for investigations and complaints.
- Collaborate with site team to develop strategy to improve process control, yield, efficiency, and productivity across the site portfolio.
- Provide oversight for technical projects to improve process control, capacity, yield, and quality.
- Engage in site and network governance meetings to influence technical agendas.
- Network globally to share best practices and control strategies for harmonization and alignment.
- Engage Pharmaceutical Product Development groups for applicable technical transfer deliverables for new molecule entities during commercialization.
Minimum Requirements
- Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Science, Engineering, or related field.
- 10+ years of experience in Quality Control and team leadership in a pharmaceutical manufacturing environment.
Additional Preferences
- Ability to influence and lead diverse groups; strong analytical and quantitative problem-solving.
- Experience with complex regulatory/business/technical issues.
- Experience with Empower; LIMS implementation/use; statistical analysis of data.
- Technical leadership, administrative and organizational skills.
- Ability to deliver highly complex and/or cross-functional work; strong project management.
- Effective communication/influence across functional groups and stakeholders.
- Strategic thinking; ability to balance short-term needs with long-term business evolution.
- Ability to build relationships with internal/external customers and partners; enthusiasm, flexibility, and ability to learn/apply technical/scientific knowledge.
Additional Information
- Onsite position.
- Travel: approximately 10–20%.
Benefits (as listed)
- Eligible for company bonus (depending on company/individual performance).
- Comprehensive benefit program including 401(k), pension, vacation, medical/dental/vision/prescription coverage, flexible benefits, life insurance/death benefits, time off/leave of absence benefits, and well-being benefits (e.g., employee assistance, fitness benefits, employee clubs/activities).
Compensation (as listed)
- Anticipated wage: $151,500–$222,200.
Application/Accommodation Instructions (as listed)
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
Main Purpose and Objectives
- Provide administrative and technical leadership for the development, performance, and maintenance of QC Labs during start-up, implementation, and day-to-day operations.
- Balance coaching/leadership of a technical staff with prioritization/staffing for routine production support, implementation of technical projects, and process optimizations.
- Ensure knowledge and application of cGMPs, global regulatory manufacturing guidance, and validation standards; partner cross-functionally to deliver technical objectives, product business plan objectives, and quality objectives.
Key Responsibilities
- Provide technical leadership; performance management, training, and development of staff.
- Maintain a safe work environment.
- Ensure GMP compliance.
- Ensure technical review and approval for documents including: investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, and technical studies.
- Partner within Quality Control and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
- Interact with regulators, customers, and other stakeholders; support internal and external agency audits.
- Provide oversight and technical excellence for investigations and complaints.
- Collaborate with site team to develop strategy to improve process control, yield, efficiency, and productivity across the site portfolio.
- Provide oversight for technical projects to improve process control, capacity, yield, and quality.
- Engage in site and network governance meetings to influence technical agendas.
- Network globally to share best practices and control strategies for harmonization and alignment.
- Engage Pharmaceutical Product Development groups for applicable technical transfer deliverables for new molecule entities during commercialization.
Minimum Requirements
- Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Science, Engineering, or related field.
- 10+ years of experience in Quality Control and team leadership in a pharmaceutical manufacturing environment.
Additional Preferences
- Ability to influence and lead diverse groups; strong analytical and quantitative problem-solving.
- Experience with complex regulatory/business/technical issues.
- Experience with Empower; LIMS implementation/use; statistical analysis of data.
- Technical leadership, administrative and organizational skills.
- Ability to deliver highly complex and/or cross-functional work; strong project management.
- Effective communication/influence across functional groups and stakeholders.
- Strategic thinking; ability to balance short-term needs with long-term business evolution.
- Ability to build relationships with internal/external customers and partners; enthusiasm, flexibility, and ability to learn/apply technical/scientific knowledge.
Additional Information
- Onsite position.
- Travel: approximately 10–20%.
Benefits (as listed)
- Eligible for company bonus (depending on company/individual performance).
- Comprehensive benefit program including 401(k), pension, vacation, medical/dental/vision/prescription coverage, flexible benefits, life insurance/death benefits, time off/leave of absence benefits, and well-being benefits (e.g., employee assistance, fitness benefits, employee clubs/activities).
Compensation (as listed)
- Anticipated wage: $151,500–$222,200.
Application/Accommodation Instructions (as listed)
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation