QA Materials Management Site Compliance

QA Materials Management Site Compliance Location Durham, NC :

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 Associate for Materials Management is responsible for the site parenteral & device materials management systems. The Materials Management associate provides Quality Oversight for the suppliers and materials utilized by the site. This position supports all Materials Management activities relative to the Site in order to ensure appropriate Quality Oversight.

Key Objectives/Deliverables:

• Work with site staff and global resources to establish site material suppliers for startup
• Coordinates the appropriate tasks to develop and maintain the approved supplier list
• Conduct material and supplier risk assessments and periodic reviews of supplier performance
• Coordinate and write Supplier, Service Provider, and Affiliate Quality Agreements, including networking with site resources to ensure compliance to associated requirements
• Provide input, guidance and recommendation for Supplier/Service Provider approval and certification activities
• Provides support to the warehouse for incoming receipt, sampling and testing
• Maintain complaint database (track supplier responses for warehouse, incoming and operations complaints)
• Provide input and guidance to site activities (e.g., six sigma, new product/process development, change controls) as material quality SME
• Be able to perform materials SAP data steward functions
• Review and Redline Materials and other GMP documents, including specifications and procedures. Provide procedure ownership and subject matter expertise, as necessary.
• Provide the voice of quality to the Material Management Governance Committee and Supplier Certification Global Committee, providing input and support as needed in order to ensure compliance
• Initiate supplier complaints (CARTs) when issues arise
• Support regulatory inspection activities as needed by providing documentation and SME support
• Track and report materials management metrics to Supplier Relationship Meetings, supplier committees, and Materials Management Governance Committee
• Lead, as required, local or global teams, committees, or other groups to resolve quality issues and ensure site compliance to Lilly Standards and external regulations

Minimum Requirements:

• Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study
• Experience working in the pharmaceutical or medical device industry in QA roles

Additional Preferences:

• Previous facility or area start up experience
• Previous equipment qualification and process validation experience
• Previous experience with SAP or other inventory management systems
• Previous experience with device and parenteral product materials
• CQA certification from the American Society for Quality (ASQ)
• Previous experience with deviation and change management systems including Trackwise
• Previous materials management and supplier management experience
• Proficiency with material management computer systems and applications including Microsoft Office products, SAP, Regulus, Veeva QDocs and TrackWise or similar systems
• Previous regulatory inspection readiness and inspection execution experience
• Strong oral and written communication and interpersonal skills
• Ability to influence externally with suppliers and resources across sites
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals
• Strong technical aptitude and ability to work with component and technical stewards
• Ability to work 8-hour days - Monday through Friday
• Ability to work overtime as required
• Ability to travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations.

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 ( 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$63,000 - $162,800

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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