Senior Manager, Qualification

Job Description Summary

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 riskbased 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 thirdparty 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

Skills Desired