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

Job Overview

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.

• 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 and 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 5–7+ years of relevant industry experience in Quality, Technical Services, Product Development, or Manufacturing of medical devices.
• Bachelor’s degree (or equivalent experience) in a technical/scientific discipline.
• 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.
• Strong attention to detail, problem‑solving, and decision‑making skills.
• Audit experience with medical devices and GMP.
• Experience with Kneat, Agile, Track Wise, 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.

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.

Compensation:
The anticipated wage for this position is $101,250 - $169,400. Full‑time employees are also eligible for a company bonus based on performance.

• 401(k) plan with company match
• Pension program
• Vacation and paid time off
• Medical, dental, vision, and prescription drug coverage
• Flexible spending accounts for health and dependent care
• Life and accident insurance
• Paid parental leave and other leave of absence programs
• Well‑being resources, including employee assistance program and fitness benefits

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.