Senior Quality Assurance Strategist
hace 1 día
About the Role
The Senior Quality Assurance Strategist is a critical position at Eli Lilly and Company, responsible for supporting the development and implementation of quality systems strategy and activities to achieve International Business Unit (IBU) goals and objectives in assigned countries or regions. As a key member of the team, this role will act as a quality consultant and leader in integrating quality requirements into business processes, ensuring consistency between global and local requirements.
Key Responsibilities:
1. Implement and manage quality systems, including Safety and Efficacy quality systems, to ensure compliance with appropriate quality and regulatory requirements.
2. Contribute to the development and review of country/region-specific quality system documents, ensuring that requirements and accountabilities are represented.
3. Approve regional and/or local required tools, resources, forms, and templates.
4. Assist in interpreting relevant regulations and guidelines and act as a contact person for global and affiliate teams.
5. Recommend new procedures or changes to existing procedures where applicable.
6. Responsible for deviations, change controls, Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed.
7. Conduct root cause analysis and implement Corrective Action and Preventative Action (CAPA) process.
8. Support the business on the application and facilitation of quality systems (deviations, notification to management, change control).
9. Support activities and processes related to external party management (such as third-party organizations, business alliance partners) as assigned.
10. Perform quality self-assessments, as needed.
11. Provide Quality Oversight for business area(s) and monitors compliance to Safety & Efficacy Quality System (SEQS).
What We Offer
- An estimated annual salary range of $85,000 - $110,000, commensurate with experience and qualifications.
- A comprehensive benefits package, including medical, dental, and vision coverage, 401(k) matching, and paid time off.
- Opportunities for professional growth and development in a dynamic and innovative industry.
Eli Lilly and Company is an equal employment opportunity employer. We welcome applications from diverse candidates and are committed to creating an inclusive work environment.
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