Manager Quality Assurance (MedTech)

Location: Raritan, New Jersey, United States of America; the position may also be located in New Jersey or Pennsylvania, with a preference for Raritan. Up to 30% travel may be required.

Base pay: $102,000–$177,100 per year.

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions across prevention, treatment, and disease management.

What you will do

• Lead quality systems, processes, and controls for external pharmaceutical manufacturing sites.
• Manage the selection, qualification, and ongoing quality oversight of external manufacturing partners.
• Lead investigations, complaint resolution, CAPA development, and resolution of complex quality and compliance issues.
• Review and approve product disposition, change controls, specifications, validation documentation, manufacturing instructions, and technical studies.
• Support health authority inspections, tech transfer, and new product introduction activities.
• Analyze quality trends, drive continuous improvement, and provide risk-based compliance guidance to cross-functional teams.

Requirements

• 8+ years of experience in an FDA- or EMA-regulated environment.
• Bachelor’s degree in a scientific, technical, or related discipline.
• Extensive knowledge of Quality Assurance, Quality Control, compliance, and current Good Manufacturing Practices for pharmaceutical production.
• Experience overseeing external partners in commercial manufacturing operations.
• Experience with Good Tissue Practices, biologics products, and aseptic pharmaceutical manufacturing.
• Strong written, oral, interpersonal, analytical, and stakeholder-influencing skills.

Nice to have

• Experience writing regulatory communications.

Culture & Benefits

• Inclusive work environment guided by the company’s Credo and equal opportunity principles.
• Pension and 401(k) savings plans, subject to applicable plan terms.
• Paid vacation, sick time, holidays, parental leave, caregiver leave, bereavement leave, volunteer leave, and military spouse time off.
• Work may involve collaboration with on-site and remote work teams.