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

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 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.
- 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.

Minimum Qualifications
- Bachelor’s degree (or equivalent experience) in a technical/scientific discipline.
- 5–7+ years of relevant 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/standards: FDA (21 CFR Parts 4, 11, 210/211, 820), ISO 13485, ISO 14971, EU/Canadian MDR, JPAL, TGA, ANVISA.
- Experience with contract manufacturers and suppliers.
- Ability to influence cross-functional teams and external partners.
- Strong written/verbal communication; basic stats and risk management.
- Ability to investigate/analyze and resolve complex quality issues.

Additional Preferences
- Audit experience with medical devices/GMP; experience with Kneat, Agile, TrackWise, Microsoft Office.
- Technical writing; explain validation/quality concepts to non-technical stakeholders.
- Strong organizational/time management and self-management; experience leading readiness assessments and driving improvements.

Additional Information
- Travel: 5–25%.
- Work authorization required in the U.S.; Lilly does not sponsor visas.
- Accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation