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Head of Quality Inspection - Spencer, NC, United States - Lilly
Description
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.
The Night Shift Manager, Quality Assurance (QA) - Device Assembly and Packaging (DAP), will initially serve as the QA representative supporting the Device Assembly and Packaging workstream overseeing commissioning and qualification at Lilly's new Concord, North Carolina site.
This role is responsible for QA technical oversight including document approvals (e.g., Commissioning and Qualification Packages, procedures) and cross-functional decision making.
As the project progresses, this role will transition to providing leadership, daily support, and oversight of GMP operations. The Manager, Quality Assurance will develop the quality on the floor programs to support GMP manufacturing. The Manager, Quality Assurance will assist with developing the training program for floor support and training QA personnel. The Manager, Quality Assurance will be responsible for managing the daily work of QA personnel.The Night Shift Sr.
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 productionManage a team of up to approximately 14 direct reports
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; 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 managementSupport inspection readiness activities.
Interact with regulatory agencies during inspections regarding cGMP issues
Ensure data integrity by design
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
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
Demonstrated technical writing 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
CQM, CQE, or CQA certification from the American Society for Quality (ASQ)
Previous experience with deviation and change management systems including Trackwise
Ability to work 8-hour days - Monday through Friday Night Shift
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
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.
Please note This email address is intended for use only to request an accommodation as part of the application process.
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.
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.
