Job Description Summary#LI-Onsite
Location: Morris Plains, NJ, United States
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. You'll 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 projects-driving a culture of proactive inspection readiness, risk based decision making, and continuous improvement.
Job DescriptionKey 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- Bachelor's 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.
Salary Range$114,100.00 - $211,900.00
Skills DesiredBusiness 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
