New · posted Oct 23
Novartis · Pharmaceuticals
Site Quality Head (Director)
- Morrisville, NC
- On-site
- Full-time
- Director
Open until filled
The role
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.
As Site Quality Head, you will lead the Quality organization for our new Small Molecule site in Morrisville, North Carolina, with a unique opportunity to build and guide the site Quality organization through ramp-up and commercialization. You will provide strategic leadership to ensure regulatory compliance, product quality, and operational excellence across manufacturing operations. You will be accountable for maintaining compliance with cGMP requirements, regulatory expectations, ISO standards, and Novartis Quality policies, while providing leadership and oversight across all site quality matters. You will develop a high-performing Quality organization, foster a strong culture of quality and continuous improvement, and partner with site leadership to support the site’s strategic and operational priorities.
What you need
• 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.
To learn more about the culture, rewards and benefits we offer our people click here.
Skills Desirednice to have
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
What you'll do
• 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 escalate 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.
Pay and benefits
$168,000 – $312,000 a year
Employer provided$168,000.00 - $312,000.00
Health, life and disability benefits
401(k) with company contribution and match
Performance-based cash incentive
Annual equity award eligibility
Vacation, personal days and holidays
Where you'll work
Morrisville, NCOn-siteOpen in Maps (opens in a new tab)
More jobs in Morrisville, NCEqual opportunity, accessibility and legal noticesNovartis's statements, word for word
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 [email protected] 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.
Job intelligence
The context around this role
Live data · October 23, 2026
Salary intelligence
How the pay compares
This role's midpoint is 15% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Director roles in the US107 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $168,000 | — | $312,000 |
| All US (middle half) | $185,500 | $209,000 | $233,750 |
This role: Novartis's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 23, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 927 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Novartis's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 22 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership8
- GMP and compliance7
- Quality systems and risk6
- Documentation and SOPs2
- Regulatory submissions2
- Data and digital systems2
- Lab testing and methods1
- Validation and qualification1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
Company hiring pulse
Novartis on Regulatory Jobs
- 14
- Open roles
- 13
- Distinct roles
- 7
- Locations
By discipline
- Quality10 71%
- Compliance & Safety4 29%
By level
- Director5 36%
- Senior & Principal5 36%
- Associate & Specialist3 21%
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Site Quality Head (Director) at Novartis
Open until filled. $168K–$312K a year, employer provided.