Manager, Quality Management Systems (Pharmaceutical)

Location: Basking Ridge, New Jersey, United States

Salary: USD 118,560–177,840 per year

Company

Innovative pharmaceutical therapies are developed and supplied across oncology, cardiovascular disease, rare diseases, and immune disorders, supported by global scientific and technology capabilities.

What you will do

• Manage and maintain the global Quality Management System, including process effectiveness, procedures, and compliance commitments.
• Identify, triage, escalate, and monitor quality issues, investigations, deviations, CAPAs, and non-conformances.
• Drive harmonized quality processes across local and global functions and support continuous improvement initiatives.
• Lead risk assessment, mitigation, quality system projects, metrics, and compliance reporting.
• Support audits and regulatory inspections, including inspection readiness, document management, and corrective action planning.
• Promote a quality culture and collaborate with clinical, commercial, and cross-functional stakeholders.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or Sciences required; a master’s degree is preferred.
• At least 4 years of professional experience managing and maintaining Quality Management Systems.
• Experience with global quality procedures, including change control, deviations, CAPA, document management, and investigations.
• Experience with pharmaceutical development or commercial quality systems involving small molecules, biologics, or advanced gene therapies.
• Strong GxP knowledge, regulatory compliance expertise, critical thinking, leadership, and cross-functional communication skills.
• Ability to manage projects and teams of significant scope and complexity while meeting compliance commitments and timelines.

Nice to have

• Experience supporting regulatory audits and inspections.
• Experience identifying and implementing new pharmaceutical regulations and quality trends.
• Master’s degree in Life Sciences, Engineering, or Sciences.

Culture & Benefits

• Work within a global pharmaceutical organization focused on innovative medicines and improved patient outcomes.
• Collaborate with local and international Quality, clinical, commercial, and functional teams.
• Participate in continuous improvement, benchmarking, professional conferences, and quality initiatives.
• Equal opportunity employment and a full-time professional position.