Clinical Quality Assurance - Program Lead (Associate Director)
About The Position
As Associate Director and Clinical Quality Assurance Program Lead, you will provide proactive, risk-based quality oversight for an assigned portfolio of clinical programmes and trials. Working with cross-functional teams, you will help keep programmes inspection ready, compliant with Health Authority requirements, and focused on patients’ safety, rights and well-being. The role provides Clinical Quality Assurance leadership and drives quality strategy across assigned programmes and trials. You will oversee quality planning and risk management, provide practical Good Clinical Practice guidance, support quality incident governance, and lead or contribute to inspection preparation, follow-up, and continuous improvement. The position is based in East Hanover, US, and is described as hybrid. Novartis is unable to provide relocation support for this role.
Requirements
- Bachelor's degree in a life science or healthcare field.
- Extensive experience in regulated activities such as Good Clinical Practice or Pharmacovigilance, in clinical development and/or Quality Assurance roles.
- Strong understanding of how clinical trials are run.
- Broad understanding of global Health Authority expectations in clinical development and deep understanding of the science of product development.
- Strong skills in Good Clinical Practice, clinical quality and/or clinical development.
- Experience managing projects.
- Ability to work independently in a global, matrix environment.
- Skills in stakeholder management, risk management, regulatory compliance, leadership, and problem solving.
Nice To Haves
- Advanced degree in life sciences or healthcare, such as a PhD, Doctor of Medicine, Doctor of Pharmacy, or Master's degree.
- Experience in audit and inspection management, including preparing Corrective and Preventive Actions and leading teams through Health Authority inspections.
Responsibilities
- Provide Clinical Quality Assurance leadership for assigned programmes and trials, applying an understanding of how departments connect and the business’s objectives.
- Drive the quality strategy within supported Global Clinical Teams and Clinical Trial Teams so quality is incorporated into trial planning and conduct.
- Monitor delivery of the annual Quality Plan for assigned programmes and studies.
- Oversee proactive quality risk management, including quality risk assessments and submission and inspection readiness activities, and confirm Clinical Trial Processes remain in control.
- Work with Country Development Quality, Development Units, and Global Clinical Team and Clinical Trial Team members to identify and resolve risks early.
- Support core governance for quality incident management, including critical and major deviations, and escalate promptly when needed.
- Provide practical guidance on day-to-day Good Clinical Practice questions arising from clinical trial deliverables.
- Partner with Country Development Quality Assurance and External Service Provider Quality Assurance on internal monitoring and quality oversight of outsourced activities.
- Lead inspection preparation and facilitation with other Research and Development Quality Assurance groups; support audit and inspection follow-up, including preparation of Corrective and Preventive Actions.
- Use audit and inspection outcomes and trends to improve trial conduct.
- Act as the Quality Assurance point of contact for defined trials and attend trial meetings to ensure quality informs decisions.
- Participate in continuous improvement work streams and help ensure identified weaknesses are addressed and improvements are sustained.
Benefits
- Performance-based bonus or cash incentive.
- Potential eligibility for annual equity awards or long-term equity awards, depending on role level and applicable parameters.
- Competitive benefits, including insurance plans, retirement plans, wellbeing resources, and global recognition programs.
- Flexible and hybrid working options, where possible.
- Minimum 14 weeks of paid parental leave.
- For eligible US-based employees: health, life, and disability benefits.
- For eligible US-based employees: 401(k) with company contribution and match.
- For eligible US-based employees: vacation, personal days, holidays, and other leaves.
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What This Job Offers
Job Type
Full-time
Career Level
Director
