A Brief OverviewThis role is responsible for labeling quality and compliance activities to ensure product labeling meets regulatory requirements, industry standards, and company policies. Oversees Product Labeling and New Markets functions while supporting Risk Management and Change Control processes. Drives continuous improvement, operational excellence, and inspection readiness across multiple teams and geographies.Provides strategic leadership for labeling development, review, approval, and lifecycle management, ensuring labeling accuracy, compliance, and product quality. Partners cross-functionally to support product launches, market expansions, quality initiatives, product changes, and risk assessments while developing talent, resolving complex compliance issues, and strengthening quality systems to support business objectives and patient safety.
What You Will Do- Manage and oversee labeling quality assurance processes and systems Oversee labeling quality processes and systems to ensure labeling accuracy, compliance, and consistency. Support labeling review, approval, document control, risk management, and change control activities while driving continuous improvement and regulatory compliance.
- Ensure compliance with industry regulations and standards for labeling Ensure labeling activities comply with applicable regulatory requirements, industry standards, and company policies through effective oversight, review, audit support, and continuous process improvement.
- Develop and implement quality improvement initiatives for labeling procedures Drive strategic quality improvement initiatives for labeling processes through process optimization, standardization, performance monitoring, and cross-functional collaboration to improve compliance, operational effectiveness, and inspection readiness.
- Monitor and evaluate labeling processes to ensure accuracy and reliability Provide oversight of labeling process performance through monitoring, trend analysis, and quality metrics to ensure labeling accuracy, reliability, compliance, and continuous improvement across the product lifecycle.
- Collaborate with cross-functional teams to address labeling-related quality issues Lead cross-functional efforts to address complex labeling quality and compliance issues, driving timely resolution, risk mitigation, and sustainable process improvements to support product quality and regulatory compliance.
- Support Change Control and Risk Management Activities Provide support and oversight for risk management and change control processes to ensure effective evaluation of changes, mitigation of risks, and compliance with quality system and regulatory requirements.
Minimum Requirements- Bachelor of Science (B.S.) Life Sciences, Engineering, Regulatory Affairs, or related technical discipline
- 5+ years Progressive experience in Quality, Quality Engineering, Regulatory Affairs, Labeling, or related functions within a regulated industry (medical device, pharmaceutical, biologic, or combination products).
- 3-5 years Experience leading cross-functional initiatives and influencing business decisions across multiple functions and organizational levels.
- First Leadership experience managing professional staff, developing talent, and leading department or functional objectives.
- Quality Assurance
- Process Improvement
- Compliance Management
- Cross-Functional Collaboration
- Risk Assessment
- Project Management
- Technical Writing
- Data Analysis
- Problem Solving
- Critical Thinking
Preferred Qualifications- Master's Degree Physical science, engineering, business, or relevant field
- Certification(s) - ASQ Quality Assurance Certified Quality Engineer certification
- Lean Six Sigma Certifications (Yellow Belt, Green Belt, Black Belt) Six Sigma certification (green belt or higher)
- Certification(s) - ASQ Quality Assurance Certified Quality Manager
Technical & Functional Skills- Expert knowledge of quality systems, quality techniques, regulatory requirements, and quality engineering principles.
- Advanced knowledge of labeling regulations, standards, and global compliance requirements.
- Thorough understanding of Quality System requirements including documentation, records management, change control, CAPA, and risk management.
- Ability to lead complex investigations, root cause analyses, and continuous improvement initiatives.
- Ability to develop and implement quality strategies, policies, and engineering standards.
- Ability to provide leadership, coaching, and development to quality engineering staff.
- Ability to collaborate and influence effectively across global cross-functional teams and senior leadership.
- Ability to make sound business decisions and balance quality, compliance, and operational objectives.
- Experience leading regulatory inspections, audits, and inspection readiness activities.
- ASQ Certification (CQE, CMQ/OE) and/or Lean Six Sigma Certification.
Benefits- Comprehensive Medical, Dental, and Vision plans
- 20 days of Paid Time Off
- 15 paid holidays
- Paid Sick Leave
- Paid Parental Leave
- 401(k)
- Employee bonuses
- And more!
- Your benefits and PTO start the date you're hired with no waiting period!
Work Authorization & Visa SponsorshipApplicants must be authorized to work in the United States without the need for employment-based visa sponsorship now or in the future. Merz will not sponsor applicants for U.S. work visa status for this opportunity. No sponsorship is available for any employment-based visas, including but not limited to H-1B, L-1, TN, O-1, E-3, H-1B1, F-1, J-1, OPT, CPT, or any other employment-based visa category.
