Senior Director Quality Control
Description:
Job Details
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.
Main Purpose and Objectives:
The Senior Director - Quality Control is part of the Senior Leadership Team of the Lilly Lebanon API site (LP1). The QC Senior Director provides administrative and technical leadership in the development, performance, and maintenance of the QC Labs throughout the start-up, implementation, and day-to-day operations of LP1.
The Sr. Dir. - QC must balance coaching a technical staff, prioritization and staffing for routine production support activities, implementation of technical projects, and process optimizations. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation. The Sr. Dir. - QC will work cross-functionally within the site, network, commercialization teams, and other functions to deliver on technical objectives, specific product business plan, and quality objectives.
In the project delivery and start-up phase of the LP1 site, the Sr. Dir. - QC will be flexible in supporting project delivery, building a new organization, developing and implementing the necessary systems and business processes required to support GMP operations, and building the site culture. This will require significant collaboration, creativity, and resilience as the site grows to a full-scale GMP manufacturing operation.
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, 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
Minimum Requirements:
Bachelor's Degree in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmaceutical Science, Engineering or a related field
10+ of experience in Quality Control and team leadership in a pharmaceutical manufacturing environment
Additional Preferences:
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
Additional Information:
Ability to travel (approximately 10-20%)
Onsite position
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 ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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 for their members and are open to all employees. Our current groups include: 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 equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., 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 and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Company
Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to "take what you find here and make it better and better." More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit.
Company info
Location 893 S Delaware St
Indianapolis
Indiana
46285
United States
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