Associate Director, Quality Assurance (Materials) Jobs at Eli Lilly and Company – Concord, NC

Eli Lilly and Company

Associate Degree jobs in North Carolina, USA – Apply for Associate Director, Quality Assurance (Materials) Jobs at Eli Lilly and Company – Concord, NC . See job descriptions, requirements, and the link to apply.

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 35,000 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.

Organization Overview

The Associate Director, Quality Assurance (QA) – Materials, will initially serve as the QA Project Lead for the Logistics workstream overseeing the materials management strategy and associated facility (e.g., warehouse) delivery at Lilly’s new Concord, North Carolina site. This role is responsible for QA technical oversight including document approvals (e.g., qualification documents, change controls, procedures, quality agreements) and cross-functional decision making. As the project progresses, this role will transition to site-based process team leadership. The Quality Assurance Associate Director for materials and logistics is responsible for the staffing, training, and leadership of the quality assurance group supporting the materials management programs including suppliers and service providers. After startup, this individual will continue to foster a strong quality culture and cultivate operational excellence through demonstrated leadership of the QA team. They will provide ongoing oversight of routine operations for all materials management activities and support services, as well as support site inspection readiness and execution.

Responsibilities

The Associate Director, Quality Assurance, will lead the start-up and routine operation of the QA organization overseeing the Materials Management and Logistics 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 materials management documents (e.g., qualification documents, change controls, procedures, quality agreements)
  • Network with cross-functional resources to ensure establishment of the materials management quality system and facilitate project delivery through support of facility (e.g., warehouse) qualification
  • Work with the Site Quality Leader to support the development of the vision, strategy and quality culture for the overall site quality assurance organization with focus on materials management, supplier and service provider governance and logistics activities.
  • Support initial recruiting, build capability, for a diverse leadership and quality assurance staff
  • Support the site to ensure a safe work environment including supporting and leading safety efforts for your team
  • Establish site material supplier program, partnering with other Lilly manufacturing sites and global materials management teams
  • Build the team to develop and maintain the approved supplier list, Quality Agreements, material and supplier risk assessments, and periodic reviews of supplier performance
  • Provide support to the warehouse and logistics for all operational quality assurance needs and materials approvals
  • Responsible for materials and supplier complaint handling
  • 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.
  • Participate in tactical and strategic business planning

Basic Requirements

  • Bachelor’s degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
  • 3+ years in pharmaceutical leadership with specific Materials QA experience, including leading or working effectively with a cross-functional group

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 materials management and supplier management experience
  • Previous experience with material management computer systems and applications including SAP, Veeva QDocs and TrackWise or similar systems
  • 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 regulatory inspection readiness and inspection execution experience

Additional Information

  • Ability to work 8-hour days – Monday through Friday; Onsite
  • Ability to work overtime as required
  • Ability to travel 10-25% during the project phase

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.

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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

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