Site Quality Head (Director)

Regulatory Toolkit; Morrisville (NC); On-site; USD 168,000 - 312,000; Full time

Job summary

Novartis in Morrisville, North Carolina is seeking a senior Quality leader to head the site Quality organization, guiding ramp-up and commercialization efforts with strategic, compliant governance across QMS and site operations.

You will lead regulatory inspections, ensure data integrity, and build a high-performing team within the Site Leadership Team, driving safety and quality culture throughout the site.

Qualifications

• University degree in Pharmacy, Chemistry, Biotechnology, or a related scientific discipline.
• 10+ years of pharmaceutical Quality/Manufacturing experience, with at least 5 years in small molecules.
• Experience leading regulatory inspections and interactions with Health Authorities.

Responsibilities

• Lead the independent site Quality organization and provide strategic leadership.
• Establish and improve the site QMS and quality governance across site operations.
• Ensure compliance with cGMP and regulatory requirements, driving inspection readiness.
• Maintain data integrity and compliant quality records across all quality systems.
• Provide GxP oversight across Manufacturing, QA, distribution, validation, and facilities.
• Lead Health Authority interactions and respond to inspection observations.
• Recruit, develop, and retain a high-performing Quality organization within the site leadership team.
• Promote Safety and Quality culture and contribute to site strategy and excellence initiatives.

Skills

Quality leadership

Regulatory experience

GxP knowledge

Quality assurance

Cross-functional leadership

People management

Education

Pharmacy/chemistry/biotech degree

Job description

Job Description Summary

Location: Morrisville, North Carolina

Please note: Novartis is unable to provide visa or immigration support for this position. Applicants must have authorization to work in the United States without requiring current or future sponsorship.

#LI-Onsite

Job Description

Key Responsibilities

• Lead the independent site Quality organization, providing strategic and operational Quality leadership as the new Small Molecule site progresses through ramp-up and commercialization.
• Establish, maintain, and continuously improve the site Quality Management System (QMS), ensuring effective Quality governance and oversight across site operations.
• Ensure compliance with cGMP, regulatory requirements, Novartis Quality Standards, and applicable ISO requirements, while driving site inspection readiness and Quality governance processes.
• Ensure product quality and effective Quality Risk Management, including appropriate management and escalation of quality issues and maintenance of data integrity and compliant quality records.
• Provide GxP oversight across Manufacturing, Quality Control, distribution, change management, validation and qualification, equipment, utilities and facilities, supplier quality, stability programs, eCompliance, and data integrity.
• Lead Health Authority interactions and regulatory inspections, ensure timely responses to inspection observations, maintain compliance with local and global regulatory requirements, and appropriately elevate critical Quality issues.
• Recruit, develop, and retain a high-performing Quality organization, including coaching and developing managers and Quality professionals, driving succession planning and talent development, and fostering employee engagement and a strong Quality culture.
• Serve as a key member of the Site Leadership Team, promoting Safety and Quality culture, supporting business continuity planning, contributing to site strategy and operational excellence initiatives, and acting as Site Head delegate when required.

Essential Requirements

• University degree in Pharmacy, Chemistry, Biotechnology, or a related scientific discipline.
• 10+ years of pharmaceutical Quality and/or Manufacturing experience. Experience must include at least 5 years of recent experience with small molecules.
• Strong Quality Assurance and Quality Control background with demonstrated knowledge of pharmaceutical quality and cGMP requirements.
• Demonstrated experience leading regulatory inspections and interactions with Health Authorities.
• Proven people leadership experience with multiple direct reports. Experience serving as a senior Quality leader within a site leadership team or similarly complex manufacturing environment is preferred.
• Experience working within multinational pharmaceutical environments, with the ability to operate effectively across site and organizational stakeholders.

Desirable Requirements

• Experience advancing operational excellence and continuous improvement within a pharmaceutical Quality organization.
• Experience supporting the ramp-up of new pharmaceutical manufacturing facilities.

The salary for this position is expected to range between $168,000 and $312,000 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.

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 [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

$168,000.00 - $312,000.00

Skills Desired

Business Acumen, Change Management, Collaboration, Communication, Continuous Improvement, Financial Acumen, Leadership, People Management, Quality Assurance (QA), Quality Compliance, Quality Management, Quality Management Systems (QMS), Risk-Based Decision Making, Risk Management, Stakeholder Management, Storytelling, Strategic Thinking