Quality Assurance Representative – Commissioning, Qualification & Commercialization (CQC-Q)

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.

Quality Assurance professional with 5–7+ years of experience supporting medical device and combination product manufacturing, technical transfer, and contract manufacturer (CM) oversight. Demonstrated ability to ensure process design, validation, and manufacturing readiness meet regulatory and quality requirements.

Key Responsibilities

• Provide QA oversight for manufacturing process design, ensuring risks to product quality are identified, mitigated, and validated.
• Lead and support technical transfer and commercialization of medical devices within the IDM portfolio.
• Assess and approve contract manufacturer (CM) Quality Management Systems (QMS), including procedures, training, and maintenance.
• Participate in design and development reviews to ensure manufacturability and compliance.
• Support process validation/qualification activities (components, subassemblies, final device) and change management initiatives.
• Conduct manufacturing readiness assessments and identify/drive remediation of quality gaps.
• Provide Computer System Validation (CSV) support as CSQA reviewer/approver.
• Participate in pFMEA reviews, internal audits, and regulatory compliance activities.
• Develop and maintain SOPs and work instructions; support continuous improvement initiatives.
• Establish and maintain Quality Agreements with contract manufacturers and suppliers.
• Provide cross-functional QA consulting and act as escalation point for technical quality issues.
• Coach and mentor junior QA team members and influence best practices across the domain.

Minimum Qualifications

• Bachelor’s degree (or equivalent experience) in a technical/scientific discipline.
• Minimum 5–7+ years of relevant industry experience in Quality, Technical Services, Product Development, or Manufacturing of medical devices.
• Strong knowledge of Quality Systems, validation/qualification, and manufacturing processes.
• Working knowledge of global regulations and standards, including:
  • FDA: 21 CFR Parts 4, 11, 210/211, 820
  • ISO 13485, ISO 14971
  • EU MDR, Canadian MDR, JPAL, TGA, ANVISA
• Experience working with contract manufacturers and suppliers.
• Demonstrated ability to influence cross-functional teams and external partners.
• Strong written and verbal communication skills.
• Basic knowledge of statistics and risk management.
• Ability to investigate, analyze, and drive resolution of complex quality issues.

Additional Preferences

• Strong attention to detail, problem-solving, and decision-making skills.
• Audit experience with medical devices and GMP.
• Experience with Kneat, Agile, TrackWise, and Microsoft Office tools.
• Demonstrated technical writing capabilities.
• Ability to explain validation and quality concepts to non-technical stakeholders.
• Experience leading manufacturing readiness assessments and driving improvements.
• Strong organizational, time management, and self-management skills.
• Ability to mentor peers and contribute to continuous improvement within the CQC domain.

Additional Information

• Travel: 5–25% (domestic and occasional international) for contract manufacturer and supplier oversight.
• Work Authorization: Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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 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

$65,250 - $169,400

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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