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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

This QA Associate Director, will lead the routine operations of the QA organization overseeing the Materials Management as well as Logistics operations at Lilly's Concord, North Carolina pharmaceutical manufacturing site. Responsibilities include technical and administrative leadership,

Key Objectives/Deliverables:

·       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.

·       Lead recruiting, building capabilities, for a diverse leadership and quality assurance staff

·       Support the site to ensure a safe work environment including supporting and leading safety efforts within the 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 

·       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

·       Ensure Inspection readiness in the relevant areas, as well as participate in key site inspections (regulatory or corporate)

·       Lead a team responsible for incoming material and disposition to meet production needs.

Basic Requirements:

·       Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.

·      Previous pharmaceutical leadership position, managing people and working effectively with cross-functional groups

·      5+ years of experience in Quality Assurance

·      Previous experience with projects, optimization and lead time reduction

·      Previous experience with regulatory inspections

Additional Skills/Preferences:

·       Computer System Quality Assurance (CSQA) Certification

·       Strong knowledge of Quality Management Systems and applicable regulatory requirements 

·       Previous experience with 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

·       Strong Crossfunctional attitude

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Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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