Senior Manager, Supplier Quality & Audits
$136,000–$187,000 year
On-siteDeerfield, Illinois, United States
Job Summary
Lead the divisional internal audit program, including audit strategy, prioritization, planning, execution oversight, and reporting across manufacturing, compounding, and design sites. Monitor audit results, compliance trends, and quality risks to inform risk-based decisions while overseeing a global auditor network for qualification and development. Provide leadership for supplier quality programs, managing supplier risk, performance monitoring, and remediation activities. Partner with site and functional leaders to support inspection readiness and collaborate with Quality, Regulatory Affairs, Procurement, and Operations teams to strengthen quality systems. Communicate program performance and key priorities to senior executive leadership. Requires a Bachelor's degree in Life Sciences or Engineering, 10+ years in Quality or Regulatory Affairs, and 50% travel.
Required Qualifications
- Bachelor's degree in Life Sciences, Engineering, or a related technical field
- 10+ years of experience in Quality, Regulatory Affairs, Manufacturing, or a related regulated industry
- 7+ years of leadership experience
- 5+ years of auditing experience
- Prior experience within the medical device industry
- Strong knowledge of global regulatory requirements governing medical device manufacturing
- Experience leading regulatory inspections and audit programs across global manufacturing operations
- Experience with FDA inspection
- Experience overseeing multi-site audit programs
- Expertise in regulated manufacturing environments
- Ability to travel up to 50%, including domestic and international travel
- Applicant must be authorized to work for any employer in the U.S.
Desired Qualifications
- Experience within pharmaceutical and/or biologics manufacturing environments
- Familiarity in pharmaceutical and biologics regulations
- Demonstrated success leading large-scale quality, compliance, regulatory, or manufacturing organizations
- Experience managing complex compliance issues, risk assessments, and quality improvement initiatives
- Exceptional leadership, communication, and relationship-building skills
- Ability to lead global cross-functional teams
- Ability to navigate complex challenges
- Ability to drive results
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