Quality Manager | Quality Management System Owner | ISO 9001 | Director Track A global manufacturer of temperature-controlled packaging solutions serving the pharmaceutical and life sciences markets is seeking a Quality Manager to lead and own quality for one of its core product lines. This is a highly visible quality leadership position responsible for the overall effectiveness, execution, and continuous improvement of the Quality Management System (QMS). The Quality Manager will serve as the primary owner of the QMS, with full responsibility for maintaining ISO 9001 compliance and driving quality performance across manufacturing operations, supplier quality, customer quality, and quality systems. Managing a small quality team, this individual will lead internal and external audits, oversee supplier qualification and performance, drive corrective and preventive actions, manage customer quality concerns through resolution, and partner closely with manufacturing, engineering, operations, and leadership teams. This is a true manufacturing quality leadership opportunity, not a support, coordinator, or compliance-focused role. The successful candidate will have demonstrated experience owning and leading a quality management system, influencing cross-functional stakeholders, and building a culture of quality across the organization. The Quality Manager will also play a key role in several new product initiatives and strategic business projects.
Key Requirements
- Demonstrated ownership of an enterprise-wide ISO 9001 Quality Management System
- Experience leading, maintaining, and continuously improving all aspects of the QMS, including documentation control, CAPA, audits, supplier quality, and management review processes
- Strong leadership experience with 5-7+ years of people management and responsibility for both strategic and day-to-day quality operations
- Proven experience managing supplier quality and supplier performance programs
- Experience leading internal, external, and certification audits
- Direct customer-facing quality experience, including complaint investigation, root cause analysis, and corrective actions
- Background within packaging, manufacturing, life sciences, medical device, pharmaceutical, consumer products, or other regulated manufacturing environments
- ISO 9001 experience required
- ISO 13485 and/or ISO 14001 experience strongly preferred
- Demonstrated ability to influence cross-functional teams and drive quality initiatives across manufacturing operations
Why This Opportunity
- Own and lead the Quality Management System for a critical product line within a growing global organization
- High-impact leadership role with responsibility for quality systems, supplier quality, manufacturing quality, and customer quality
- Excellent visibility with executive leadership and a clearly defined path toward Director-level responsibility
- Opportunity to influence new product development and strategic quality initiatives across the business
- Competitive compensation package, comprehensive benefits, 401(k) match, and hybrid work flexibility (4 days onsite, 1 day remote)