Senior Manager, Qualification

Novartis • Morris Plains, NJ

13h • Onsite

About The Position

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.

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

Nice To Haves

• 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

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

Benefits

• health, life and disability benefits
• a 401(k) with company contribution and match
• a variety of other benefits
• a generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees