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

Position: 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, 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.

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.

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