Manager, US PS&PV Quality & Compliance Excellence

Socket.dev; East Hanover (NJ); Hybrid; USD 120,000 - 222,000; Full time

Job summary

Novartis in East Hanover, NJ seeks a Senior Pharmacovigilance Quality professional to lead quality and compliance initiatives across Patient Safety and PV operations. You will drive inspection readiness, guide regulatory compliance, and collaborate with global teams to uphold patient safety standards.

This role focuses on managing deviations and CAPAs, analyzing quality trends, and delivering continuous improvement across regulatory frameworks.

Qualifications

• Advanced Pharmacovigilance knowledge including compliance and inspection readiness.
• Master of Science, Doctor of Pharmacy, or equivalent.
• Significant experience in Pharmacovigilance quality and regulatory functions.
• Strong understanding of global PV regulations and industry standards.
• Proven experience supporting audits, inspections, and investigations.
• Excellent stakeholder management and cross-functional collaboration skills.
• Strong analytical and problem-solving capabilities; excellent written and verbal English.

Responsibilities

• Lead quality and compliance initiatives across Patient Safety and Pharmacovigilance operations.
• Drive continuous improvement programs to strengthen quality systems and processes.
• Support inspection readiness activities and regulatory health authority inspections.
• Monitor compliance metrics and identify opportunities for risk mitigation.
• Provide expert guidance on Pharmacovigilance regulations, policies, and procedures.
• Partner with stakeholders to implement quality improvements and compliance strategies.
• Manage deviation, corrective action, and preventive action activities effectively.
• Analyze quality trends and develop actions to improve performance.
• Contribute to governance activities and quality review processes.
• Support training initiatives to enhance quality and compliance awareness.

Skills

Pharmacovigilance

Quality systems

Audit readiness

Regulatory intelligence

Stakeholder management

Cross-functional collaboration

English communication

Education

Master of Science or Doctor of Pharmacy

Job description

Job Description Summary

Location: East Hanover, New Jersey

#LI-Hybrid

Relocation Support: This role is based in East Hanover, New Jersey. Novartis is unable to offer relocation support: please only apply if accessible.

Are you passionate about advancing patient safety through quality and compliance excellence?

Join Novartis and play a pivotal role in strengthening Pharmacovigilance quality systems, driving continuous improvement, and ensuring inspection readiness across the organization. In this highly visible role, you will collaborate with cross-functional teams, influence strategic initiatives, and help maintain the highest standards of compliance that ultimately support better outcomes for patients worldwide.

Job Description

Key Responsibilities

• Lead quality and compliance initiatives across Patient Safety and Pharmacovigilance operations.
• Drive continuous improvement programs to strengthen quality systems and processes.
• Support inspection readiness activities and regulatory health authority inspections.
• Monitor compliance metrics and identify opportunities for risk mitigation.
• Provide expert guidance on Pharmacovigilance regulations, policies, and procedures.
• Partner with stakeholders to implement quality improvements and compliance strategies.
• Manage deviation, corrective action, and preventive action activities effectively.
• Analyze quality trends and develop actions to improve performance.
• Contribute to governance activities and quality review processes.
• Support training initiatives to enhance quality and compliance awareness.

Essential Requirements

• Advanced Pharmacovigilance knowledge, including compliance, quality, inspection readiness, procedures, and regulatory intelligence.
• Advanced scientific or healthcare degree such as Master of Science, Doctor of Pharmacy, or equivalent.
• Significant experience in Pharmacovigilance quality, compliance, or related functions.
• Strong understanding of global Pharmacovigilance regulations and industry standards.
• Proven experience supporting audits, inspections, and compliance investigations.
• Excellent stakeholder management and cross-functional collaboration skills.
• Strong analytical, problem-solving, and continuous improvement capabilities.Excellent written and verbal communication skills in English.

Desirable Requirements

• Experience leading complex quality improvement initiatives in a global organization.
• Knowledge of quality risk management and inspection readiness programs.

The salary for this position is expected to range between $119,700 and $223,000 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.

Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards:

Learn about all the ways we’ll help you thrive personally and professionally.

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 & 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.

Salary Range

$119,700.00 - $222,300.00

Skills Desired

Employee Training, Pharmacovigilance, Safety Science, Waterfall Model