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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.
Organization Overview:
Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site, in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company’s manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Concord site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don’t want to miss!
Responsibilities:
The Day Shift Senior Manager, Quality Assurance, will support the start-up and routine operation of the QA organization overseeing the Device Assembly and Packaging operations at Lilly’s Concord, North Carolina pharmaceutical manufacturing site. Responsibilities include technical and administrative leadership, as well as project management.
- Serve as technical resource to review and approve technical documents
- Network with cross-functional technical project delivery team to ensure equipment and systems comply with quality requirements and are implemented with a Quality by Design framework
- Work with the Associate Director, Quality Assurance to support the development of the vision, strategy and quality culture for the overall site quality assurance organization with focus on the device and packaging programs.
- Support initial recruiting, build capability, for a diverse leadership and quality assurance staff to support qualification, validation and routine production
- Manage a team of approximately 14 direct reports
- Support the site to ensure a safe work environment including supporting and leading safety efforts for your team
- Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures and controls
- Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
- Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment
- Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc.
- Network with global and other device assembly sites to understand best practices and share knowledge.
- Work cross-functionally with the area process teams for metrics reviews, operational support, and issue/deviation management
- Support inspection readiness activities.
- Interact with regulatory agencies during inspections regarding cGMP issue
- Ensure data integrity by design
Basic Requirements:
- Bachelor’s degree in a science, engineering, pharmaceutical-related field of study or equivalent experience.
- 5+ years in pharmaceutical leadership with specific QA experience, including leading or working effectively with a cross-functional group
- Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for employment positions on the B or S paths or at levels M1-M2 or R1-R3.
Additional Skills/Preferences:
- Commit to successfully maintain Lilly Computer System Quality Assurance (CSQA) Certification
- Strong knowledge of Quality Management Systems and applicable regulatory requirements
- Previous experience directly supporting a pharmaceutical manufacturing operation
- Excellent interpersonal, written and oral communication skills
- Strong technical aptitude and ability to train and mentor others
- Demonstrated technical writing skills
- Demonstrated problem-solving and decision-making skills
- Previous facility or area start up experience
- Previous equipment qualification and process validation experience
- Previous experience with highly automated combination products and packaging equipment
- Previous experience with Manufacturing Execution Systems and electronic batch release
- CQM, CQE, or CQA certification from the American Society for Quality (ASQ)
- Previous experience with deviation and change management systems including Trackwise
Additional Information:
- Ability to work 8-hour days – Monday through Friday Day Shift (not eligible for remote work)
- Ability to work overtime as required
- Ability to travel 10-25% or potentially relocate during the project phase to support the design and staffing of the facility
- May be required to respond to operational issues outside of core business hours and days
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ***************@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
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