Senior Manager Quality Engineering-Labeling

About Us

Founded in 1908, Merz is a successful, family‑owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award‑winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics.

About the Role

This role is responsible for labeling quality and compliance activities to ensure product labeling meets regulatory requirements, industry standards, and company policies. It 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, and provides strategic leadership for labeling development, review, approval, and lifecycle management.

Responsibilities

• Manage and oversee labeling quality assurance processes and systems.
• Oversee labeling quality processes to ensure accuracy, compliance, and consistency; support labeling review, approval, document control, risk management, and change control activities while driving continuous improvement and regulatory compliance.
• 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, including process optimization, standardization, performance monitoring, and cross‑functional collaboration.
• Monitor and evaluate labeling processes to ensure accuracy, reliability, compliance, and continuous improvement across the product lifecycle.
• Lead cross‑functional efforts to address complex labeling quality and compliance issues, driving timely resolution, risk mitigation, and sustainable process improvements.
• 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.) in Life Sciences, Engineering, Regulatory Affairs, or a 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 in physical science, engineering, business, or a relevant field.
• ASQ Quality Assurance Certified Quality Engineer (CQE) certification.
• Lean Six Sigma certifications (Yellow Belt, Green Belt, Black Belt) or Six Sigma certification (green belt or higher).
• ASQ Quality Assurance Certified Quality Manager (CMQ/OE) certification.
• Additional ASQ certifications (CQE, CMQ/OE) and/or Lean Six Sigma certification.

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.

Benefits

• Comprehensive Medical, Dental, and Vision plans.
• 20 days of Paid Time Off.
• 15 paid holidays.
• Paid Sick Leave.
• Paid Parental Leave.
• 401(k) retirement plan.
• Employee bonuses.
• Additional benefits and perks.
• Benefits and PTO start on the date you’re hired with no waiting period.

Work Authorization

Applicants 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.