Quality Specialist/ Division Quality Program Lead

We are seeking a highly motivated Division Quality Program Lead to drive complex, cross-functional initiatives across our organization.

In this role, you will lead end-to-end program execution—partnering with Quality, Regulatory, R&D, Supply Chain, and Operations—to ensure relabeling or other initiatives and activities are delivered on time, compliant, and operationally effective.

This is a high-visibility role ideal for someone who thrives in fast-paced, regulated environments and excels at bringing structure and alignment to complex programs.

What You Will Do

• Lead and execute end-to-end relabeling programs from planning through completion
• Drive alignment across cross-functional stakeholders on scope, timelines, and execution strategy
• Ensure compliance with quality systems, regulatory requirements, and change control processes
• Oversee development of key documentation (e.g., work instructions, lot records, traceability documentation)
• Coordinate site readiness, including materials, equipment, and trained personnel
• Manage logistics and inventory movement to support relabeling execution
• Identify and mitigate program risks, escalating issues as needed
• Provide clear, structured updates to leadership and key stakeholders
• Other responsibilities as assigned

What You Need

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 3+ years of experience in Quality, Operations or Manufacturing
• Proven ability to lead cross-functional programs or projects
• Strong understanding of quality systems (e.g., NC/CAPA, change control) and regulatory environments (medical device or similar highly regulated industry)
• Ability to manage multiple priorities and drive execution in a dynamic environment

Preferred Qualifications

• Experience with relabelling, remediation, or field action programs
• Experience working across global or multi-site operations
• Familiarity with ERP systems and product traceability

What Makes You Successful

• Strong leadership and influence skills across functions
• Clear, concise communicator (comfortable with executive updates)
• Highly organized with strong attention to detail
• Proactive problem solver who can navigate ambiguity
• Results-driven with a strong sense of ownership

Why Join Us

• Opportunity to lead high-impact, division-level programs
• Visibility with cross-functional and leadership teams
• Ability to shape processes and drive operational improvements
• Collaborative, fast-paced environment with meaningful outcomes

Work Environment

• May require travel to manufacturing or distribution sites
• Interaction with operational and regulated environments