Lilly Associate Director- QA Site Compliance in Durham, North Carolina
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.
The Quality Assurance Compliance Associate Director is the site Quality representative who, irrespective of other responsibilities, has the responsibility and authority that includes ensuring that processes needed for the quality management system are documented, reporting to top management on the effectiveness of the quality management systems and for improvement, ensuring the promotion of awareness of management system requirements throughout the organization. The QA Compliance Associate Director is also responsible for the staffing, training, and leadership of the site compliance group in the design and development of key site compliance systems and procedures to support the implementation of the overall site Quality Management System.
Support the Sr. Director QA Compliance in the development of the site organization, oversight of the Quality Management System, and execution of site Quality programs
Ensures that quality system requirements are effectively established and effectively maintained in accordance with 21CFR210, 211, 600, 820 and ISO13485
Leads reporting of the performance of the quality systems to site leadership and site flow/process teams management
Build a diverse and capable site compliance organization linked to the Lilly global organization in support of implementing and maintaining the site Quality Management Programs, systems, and procedures, including:
Deviation Management QMS
Change Management QMS
CAPA Management QMS
Product Complaints QMS
GMP Library and document control
QA for QCL
Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
Supervise, coach, and aid in development, performance management, ensure a fair and equitable work environment
Network with global and other parenteral sites to understand best practices, share knowledge, and participate in tactical and strategic business planning
Work cross-functionally across all areas of the site for coordination, planning, and execution of activities
Setting of area human resource and business plan goals
Plans and supports execute site regulatory agency inspections
Assists Sr. Director QA Compliance in coordination and execution of the site Quality Plan.
Requirements (Education, Experience, Training):
Experience working in the pharmaceutical industry in parenteral or device manufacturing QA/QC roles
Bachelor's Degree (4-year college degree) in science, engineering, or computer systems
Strong knowledge of Quality Management Systems, Site Compliance processes, and regulatory requirements (CFRs, ISO, etc.)
Previous management or leadership experience including leading or working effectively with a cross functional group
Previous regulatory inspection readiness front room experience
Understanding of compliance requirements and regulatory expectations
Excellent interpersonal, written, and oral communication skills
Strong technical aptitude and ability to train and mentor others
Previous work with combination products and experience with GMP/ISO regulations and notified bodies
CQM or CQE certification from the American Society for Quality (ASQ)
Project management experience
Previous experience with CAPA systems including TrackWise
Ability to work 8-hour days – Monday through Friday
May require support outside of regular schedule (weekend days or off-hours) in support of continuous (24/7) manufacturing operations.
Ability to travel up to 10% to Indianapolis for meetings and coordination with global regulatory organizations
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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.