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Manager-QA Site Compliance Team

Durham, North Carolina

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Req ID R-3822 Title Manager-QA Site Compliance Team City Durham State / Province North Carolina Country United States

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 39,000 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.

Position Brand Description:

Lilly is a fortune 500 company in operation for over 140 years creating high-quality medicines for our patients while living our company values of Integrity, Excellence, and Respect for People in everything that we do. 

Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina.  This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. 

The Quality Assurance Compliance Manager is 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.  After start up, the manager will continue to help build a strong quality culture and lead the compliance team in execution of key site quality programs as well as site inspection readiness and execution.

Key Objectives/Deliverables:

  • Support the Site Quality Leader in the development of the site organization, creation of the Quality Management System implementation plan, and execution of site Quality programs.

  • Support the development of the overall site operational readiness plan.

  • Build a diverse and capable site compliance organization linked to the Lilly global organization in support of creating and implementing the site Quality Compliance Programs, systems, and procedures, including:

    • Device and Parenteral Regulatory

    • Site Quality Plan, Deviation, Change, and CAPA programs

    • Internal – External Auditing Program

    • Supplier Management Program

    • Complaints

    • CSQA & FUME Capability

  • 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

  • Coordinating site regulatory strategy with the global regulatory group

  • Plans and supports execute site regulatory agency inspections

  • Coordinates the creation and execution of the site Quality Plan

  • Plans and executes the site self-assessment program

Basic Requirements:

  • Bachelor of Science in a science, engineering, or computer systems degree.

  • At least 7 years working in the pharmaceutical industry in parenteral or device manufacturing QA/QC roles.

  • Strong knowledge of Quality Management Systems, Site Compliance processes, and regulatory requirements (CFRs, EU MDR, ISO, etc).

  • Previous management or leadership experience including leading or working effectively with a cross functional group.

  • Previous regulatory inspection readiness and inspection execution experience.

  • Previous experience with CAPA programs, supplier qualifications, quality agreements, etc.

  • Deep understanding of compliance requirements and regulatory expectations

  • ​Ability to travel up to 10% to Indianapolis for meetings and coordination with global regulatory organizations.

  • Ability to work 8 hour days – Monday through Friday

  • Ability to work overtime as required

Additional Preferences:

  • Previous work with combination products or devices with experience with US/EU regulations and notified bodies.

  • Excellent interpersonal, written and oral communication skills

  • Strong technical aptitude and ability to train and mentor others

  • Previous facility or area start up experience.

  • CQM or CQE certification from the American Society for Quality (ASQ)

  • Project management experience

  • Previous CSQA experience

  • Previous experience with CAPA systems including Trackwise

Other Information:

  • The position is for the Lilly RTP site but will allow for a flexible working environment with the ability to work remotely or at the site based on the project phase and site activities, and depending on busness need.

  • Tasks may require repetitive motion (e.g., keyboarding).

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 ( Lilly_Recruiting_Compliance@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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-3822.

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.

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