Novartis Group Companies

Novartis Group Companies

Head Quality Systems and Compliance (Assoc Dir)

Durham

Sponsorship not specifiedDetected 6 hours ago
CompliancePerformance ManagementGMPFDA RegulatoryResearchLeadershipCollaborationGxP

About the role

  • Band Level 5 Job Description Summary Location: Morrisville, NC Join Novartis as our QA Compliance and Systems Head and help shape the quality foundation that enables the delivery of medicines to patients worldwide.
  • You will oversee Quality Systems, Compliance, Audit and Inspection Readiness, Data Integrity, Supplier Quality, and Validation programs while partnering across Quality, Manufacturing, Engineering, and Regulatory functions.
  • The salary for this position is expected to range between $138,600 and $257,400 per year.

Responsibilities

  • Partner with Manufacturing, Quality Control, Validation, Technical Operations, Engineering, and Regulatory teams to support site operations, technology transfers, qualifications, and validation activities.
  • Lead investigations of deviations, out-of-expectation events, complaints, and compliance issues, ensuring timely and effective resolution.
  • Oversee supplier quality, regulatory compliance, training governance, and risk management programs that support sustainable inspection readiness.
  • Lead, coach, and develop the QA Compliance and Systems team through effective resource planning, performance management, talent development, training governance, and sustained training compliance.
  • Advance digital enablement and continuous improvement initiatives that strengthen quality performance, simplify processes, and support site transformation.
  • Demonstrated leadership experience managing teams, developing talent, driving performance, fostering training compliance, and building a culture of accountability and collaboration.
  • Lead the site Quality Management System and ensure compliance with Novartis Quality Manual, current Good Manufacturing Practice requirements, and regulatory standards.
  • Proven ability to lead risk management, continuous improvement, and compliance initiatives in highly regulated manufacturing environments.

Requirements

  • Bachelor of Science or Master of Science in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related scientific discipline; advanced degree preferred.

Nice to have

  • Bachelor of Science or Master of Science in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related scientific discipline
  • advanced degree preferred.
  • Minimum 8-10 years of experience in pharmaceutical manufacturing, which may include expert roles in Production, Manufacturing Science and Technology, Quality, or Engineering.
  • Prior experience in oral solid dose manufacturing preferred.

Skills

  • Business Acumen, Collaboration, Data Integrity, Decision Making, Leadership, Risk Management, Strategic Planning

Compensation

  • $138,600.00 - $257,400.00
  • 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.

Benefits

  • Drive continuous inspection readiness and lead preparation for corporate audits, customer audits, external audits, and Health Authority inspections.
  • 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.

Company info

  • We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Equal opportunity

  • The Novartis Group of Companies are Equal Opportunity Employers.
  • Accessibility and reasonable accommodations
  • The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities.
  • Please include the job requisition number in your message.
Apply directly at Novartis Group Companies →Create a free account for alerts like thisView Novartis Group Companies immigration profile

This listing is sourced directly from Novartis Group Companies's careers page and normalized into a canonical job model.