This role is based in Morris Plains, NJ, United States. Novartis is unable to offer relocation support: please only apply if accessible.
This is a pivotal leadership opportunity for an experienced qualification professional who wants to shape how high quality medicines are delivered at scale. As Senior Manager, Qualification, you will play a critical role in ensuring equipment and instruments, utilities, and computerized systems are qualified to the highest regulatory and compliance standards, directly supporting patient safety and product integrity. Youll lead and develop a high performing qualification team, partner closely with Quality and Engineering, and act as a trusted subject matter expert during inspections and complex projectsdriving a culture of proactive inspection readiness, risk based decision making, and continuous improvement.
Job Description
Key Responsibilities
Lead site qualification strategy for equipment and instruments, utilities, and computerized systems across commercial and clinical operations
Own and maintain the site qualification master plan, validation schedules, and periodic review programs
Serve as site subject matter expert supporting internal and external inspections and inspection readiness activities
Drive proactive inspection readiness programs and promote a strong quality and compliance culture
Develop and implement risk‑based qualification strategies aligned with regulatory and company standards
Manage qualification resources, including contractors, budgets, forecasting, and financial stewardship
Review and approve qualification documentation including protocols, reports, risk assessments and requirement trace matrices
Partner with Quality, Engineering, and project teams to ensure compliant and efficient project execution
Provide coaching, development, and performance management for the qualification team
Monitor project progress, identify risks, and communicate roadblocks and mitigation plans to stakeholders
Essential Requirements
Bachelors degree in engineering, science, or a related technical discipline
Minimum of 7 years of experience in engineering, commissioning, qualification, and validation within pharmaceutical or biotechnology manufacturing, including equipment and computer systems validation
Minimum of 5 years of proven people leadership experience, including coaching, developing, and managing technical teams
Demonstrated expertise qualifying equipment and instruments, utilities, and computerized systems
Strong working knowledge of United States Food and Drug Administration regulations, including Title 21 Code of Federal Regulations Parts 11, 210, and 211
Understanding of international quality guidelines, including International Council for Harmonisation Q8, Q9, and Q10
Experience managing third‑party resources, including both contracted and outsourced services
Excellent written and verbal communication skills, including technical documentation and inspection interaction
Desirable Requirements
Experience supporting regulatory inspections as a site subject matter expert for commissioning and qualification activities
Demonstrated ability to implement continuous improvement or cost optimization initiatives within qualification or validation programs
The salary for this position is expected to range between $114,100 and $211,900 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.
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 us.reasonableaccommodations@novartis.com or 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.
Salary Range $114,100.00 - $211,900.00
Skills Desired Business Continuity, Cost Management, Data Analytics and Digital, Decision Making, Engineering Operations Management, Engineering Technical Expertise, GDP Knowledge, gmp knowledge, HSE Knowledge, Manufacturing Process (Production), Operational Excellence, Problem Solving, Project Management, Quality Compliance, Resilience and Risk Management, Resource Planning and Forecasting, Risk Management, Stakeholder Management, Vendor Management
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
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