Assoc Director Quality Systems&Compliance

Novartis • Millburn, NJ

2d • $138,600 - $257,400 • Onsite

About The Position

Band Level 5 Job Description Summary Internal job title: Head of Quality Systems and Compliance Location: Millburn, NJ USA Relocation Support: This role is based in Millburn, US. Novartis is unable to offer relocation support: please only apply if accessible. Step into a pivotal leadership role where you’ll shape the quality and compliance foundation for cutting-edge radioligand therapies (RLT) at Novartis. As Head of Quality Systems and Compliance, you will drive a culture of quality excellence across the Millburn site—strengthening systems, anticipating risk, and ensuring inspection readiness while enabling the delivery of safe, life-changing medicines to patients worldwide. This is a high-impact opportunity to partner with site leadership, influence strategic decisions, and elevate performance through data-driven insights and continuous improvement.

Requirements

• Bachelor of Science in Chemistry, Biology, Pharmacy, or a related scientific discipline; an advanced degree in Quality, Regulatory, Business, Healthcare, Pharmacy, or a scientific field is preferred
• Minimum ten years of experience in quality systems, quality or regulatory compliance, or Operational GxP areas (like Manufacturing or Development, QC/QA Supplier Quality and/or Post Market Quality within the pharmaceutical, diagnostic and/or medical device industries.
• Demonstrated experience leading and developing high-performing teams
• In-depth knowledge of cGMP, applicable FDA Regulations (e.g., 21 CFR 4, 7, 11, 211, 212, 314, 803, 806, 820), ICH Guidelines, EU Pharmaceutical Regulations and Directives, ISO Standards, etc.
• Understanding of United States Pharmacopeia (USP), European Pharmacopeia (EP), American Chemical Society (ACS).
• Proven experience leading health authority audits and inspections including front room / back room, readiness, strategy and response to findings / observations.

Nice To Haves

• Prior experience with aseptic manufacturing environments
• Experience in advanced therapies (Cell and Gene Therapy, Radioligand Therapy, etc.)

Responsibilities

• Act as Deputy to the Site Quality Head on all aspects of site quality inclusive of signing and approving Good Manufacturing Practice and other documents on behalf of the Quality Head as needed
• Lead and develop a high-performing quality team, allocating resources to meet critical timelines and site objectives
• Oversee and continuously enhance Quality Management Systems to ensure regulatory compliance and operational effectiveness
• Define, monitor, and report Site Quality performance metrics, providing insights and transparency to site leadership
• Lead Quality Review Board activities, identifying risks and ensuring timely mitigation and escalation when needed
• Manage complaints, recalls, returns, field alert reports, and facilitate escalations
• Lead the Corrective and Preventive Action Review Board, ensuring robust investigations and effective corrective actions
• Develop and execute strategies for inspection readiness, including audit preparation, execution, and response planning
• Coordinate and monitor Site Quality Plans, risk assessments, and gap assessments to drive compliance improvements
• Foster a strong quality culture by promoting accountability, continuous improvement, and compliance excellence across the site

Benefits

• health, life and disability benefits
• a 401(k) with company contribution and match
• a variety of other benefits
• a generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

• Job Type: Full-time
• Career Level: Senior