Clinical Quality Assurance - Program Lead (Associate Director)

U014 (FCRS = US014) Novartis Pharmaceuticals Corporation; East Hanover (NJ); Hybrid; USD 139,000 - 257,000; Full time

Benefits offered by this job

Hybrid work options

Performance-based bonus

Equity awards

Job summary

Novartis Pharmaceuticals Corporation in East Hanover, NJ, seeks an Associate Director with Clinical Quality Assurance program leadership to provide risk-based quality oversight for clinical trials. You will work with cross-functional teams to maintain inspection readiness, ensure regulatory compliance, and protect patient safety.

The role emphasizes leading QA strategy, monitoring the Quality Plan, and collaborating with global teams to address quality risks, deviations, and CAPAs.

Qualifications

• Bachelor's degree in life science or healthcare field.
• Extensive experience in regulated activities such as Good Clinical Practice or Pharmacovigilance.
• Strong understanding of how clinical trials are run.
• Broad understanding of global Health Authority expectations in clinical development, and a 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.

Responsibilities

• Provide Clinical Quality Assurance leadership for your assigned programmes and trials, drawing on a clear view of how departments connect and what the business needs to achieve.
• Drive the quality strategy within the Global Clinical Team and Clinical Trial Team you support, so that quality is built into how each trial is planned and run.
• Monitor delivery of the annual Quality Plan for your assigned programmes and studies, so that agreed quality actions stay on track.
• Oversee the proactive quality risk management process, including quality risk assessments and submission and inspection readiness activities, and confirm that Clinical Trial Processes remain in control.
• Work with Country Development Quality, Development Units and members of the Global Clinical Team and Clinical Trial Team to detect risks early and make sure they are resolved.
• Answer day-to-day Good Clinical Practice questions that arise from clinical trial deliverables, giving teams clear and practical guidance.
• Partner with Country Development Quality Assurance and External Service Provider Quality Assurance to lead initiatives on internal monitoring and on quality oversight of outsourced activities.
• Lead inspection preparation and facilitation with other Quality Assurance groups in Research and Development Quality, and support audit and inspection follow-up, including preparing Corrective and Preventive Actions, then use audit and inspection outcomes and trends to improve how trials are conducted.
• Act as the Quality Assurance point of contact for your defined trials, attend their meetings so quality shapes decisions, and take an active part in continuous improvement work streams so that identified weaknesses are addressed and the improvements last.

Job description

Job Description Summary

Do you want your quality expertise to protect patients and strengthen the clinical trials that bring new medicines to them? 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 closely with cross-functional teams, you will keep programmes inspection ready, compliant with Health Authority requirements and focused on patients' safety, rights and well-being.

Location: East Hanover, US #LI-Hybrid

This role is based in East Hanover, US. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Job Description Responsibilities

• Provide Clinical Quality Assurance leadership for your assigned programmes and trials, drawing on a clear view of how departments connect and what the business needs to achieve.
• Drive the quality strategy within the Global Clinical Team and Clinical Trial Team you support, so that quality is built into how each trial is planned and run.
• Monitor delivery of the annual Quality Plan for your assigned programmes and studies, so that agreed quality actions stay on track.
• Oversee the proactive quality risk management process, including quality risk assessments and submission and inspection readiness activities, and confirm that Clinical Trial Processes remain in control.
• Work with Country Development Quality, Development Units and members of the Global Clinical Team and Clinical Trial Team to detect risks early and make sure they are resolved.
• Support core governance for quality incident management, including critical and major deviations in your programmes, and escal...
• Answer day-to-day Good Clinical Practice questions that arise from clinical trial deliverables, giving teams clear and practical guidance.
• Partner with Country Development Quality Assurance and External Service Provider Quality Assurance to lead initiatives on internal monitoring and on quality oversight of outsourced activities.
• Lead inspection preparation and facilitation with other Quality Assurance groups in Research and Development Quality, and support audit and inspection follow-up, including preparing Corrective and Preventive Actions, then use audit and inspection outcomes and trends to improve how trials are conducted.
• Act as the Quality Assurance point of contact for your defined trials, attend their meetings so quality shapes decisions, and take an active part in continuous improvement work streams so that identified weaknesses are addressed and the improvements last.

Essential for the role

• 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 in Quality Assurance roles.
• Strong understanding of how clinical trials are run.
• Broad understanding of global Health Authority expectations in clinical development, and a 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.

Desirable for the role

• 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.

Benefits & Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. Expected Annual Base Salary Range for role: $138,600 to $257,400 The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Long-term equity awards granted at group level may also be part of your package. Further details will be provided during the application process. Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics. Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

USA - Benefit Statement: 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.

Salary Range $138,600.00 - $257,400.00

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, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

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 to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Skills Desired

• Business Acumen
• Business Partnerships
• Change Management
• Communication
• Continuous Improvement
• Data Integrity
• Digital Fluency
• Ensure Compliance
• GMP Operations
• Good Laboratory Practices (GLPs)
• Good Manufacturing Practices (GMP)
• Leadership
• Managing Ambiguity
• Organizational Savvy
• Problem Solving
• Process Improvements
• Quality Assurance (QA)
• Quality Compliance
• Quality Management
• Quality Management Systems (QMS)
• Regulatory Compliance
• Risk Management
• Stakeholder Management
• Storytelling

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together.

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