Senior Director Quality Control

Lilly • Lebanon, IN

101d • $151,500 - $222,200

About The Position

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. Lilly is currently constructing an advanced manufacturing facility for production of APIs (small molecule and peptide) located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.

Requirements

• Bachelor’s Degree in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmaceutical Science, Engineering or a related field
• 10+ years of experience in Quality Control and team leadership in a pharmaceutical manufacturing environment

Nice To Haves

• Ability to influence and lead diverse groups
• Experience with complex regulatory, business, or technical issues for pharmaceutical manufacturing
• Strong analytical and quantitative problem-solving skills
• Experience with Empower software
• Experience with LIMS implementation and use within a manufacturing environment
• Experience with statistical analysis of data
• Technical leadership, administrative and organizational skills
• Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional
• Demonstrated Project Management skills and ability to coordinate complex projects
• 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
• Ability to build relationships with internal and external customers and partners
• Enthusiasm for changes, team spirit and flexibility
• Demonstrated ability to learn & apply technical/scientific knowledge

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, technical studies, etc.
• 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, or other outside stakeholders on business issues or in support of internal and external agency audits
• Ensure adequate oversight and technical excellence for investigations and complaints
• Collaborate with site team to develop the strategy for the technical agenda to improve process control, yield, efficiency and productivity for all products within the site portfolio
• Provide oversight for technical projects to improve process control, capacity, yield, and quality
• Ensure adequate technical representation and engagement within the site and network governance meetings to influence technical agendas
• Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites
• Engage and influence Pharmaceutical Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization

Benefits

• 401(k)
• Pension
• Vacation benefits
• Medical, dental, vision and prescription drug benefits
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• Life insurance and death benefits
• Certain time off and leave of absence benefits
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees