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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.

Job Description

Key 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

Essential 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.

Desirable Requirements

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

The salary for this position is expected to range between $138,600 and $257,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

To learn more about the culture, rewards and benefits we offer our people click here.

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EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

Salary Range

$138,600.00 - $257,400.00

Skills Desired

Business Acumen, Business Partnering, Collaboration, Communication Skills, Continuous Improvement mindset, Data Integrity, Dealing With Ambiguity, Decision Making, Digital saviness, Leadership, Regulatory Requirements knowledge, Risk Management, Smart Risk Taking