Description

Job Description Summary
#LI-Onsite

Location: Millburn, NJ, USA

Relocation Support: This role is based in Millburn, NJ, USA. Novartis is unable to offer relocation support; please only apply if accessible.

At Novartis, we are pioneering the future of cancer treatment through Radioligand Therapy (RLT) - a powerful fusion of nuclear medicine and precision oncology. As we expand our global RLT manufacturing footprint, we seek passionate, purpose-driven individuals to help deliver life-changing therapies worldwide. As Head of Site QA Operations, you will lead quality oversight for Production, Quality Control testing, and Quality Engineering/Validation. You will foster a culture of excellence and ensure compliance that safeguards patient trust. This is your chance to make a meaningful impact on global healthcare.

Job Description

Key Responsibilities

• Lead and inspire the Site QA Operations team, including QA Shop Floor, QA Batch Release, and QA Engineering, fostering a culture of excellence and accountability.
• Act as Responsible Person for timely and compliant final product disposition decisions.
• Drive strategic resource allocation and capacity planning to meet GxP and Novartis standards.
• Champion continuous improvement and empower teams to deliver robust quality systems across operations.
• Represent the site in FDA and regulatory interactions, ensuring successful submissions and compliance.
• Oversee audits and inspections, setting readiness strategies and guide teams through responses.
• Build and mentor future leaders, promoting collaboration and a strong quality culture across the organization.

Essential Requirements

• Bachelors degree in Chemistry, Biology, Pharmacy, Biochemistry, Engineering, or related experience; advanced degree preferred.
• 10 years in Quality Assurance, Quality Control, Quality Systems, Compliance, Operational GxP area(s) (Manufacturing/Development) within pharmaceutical or medical device industries.
• Proven track record of leading a Quality Assurance organization and developing high-performing teams.
• Prior experience with aseptic pharmaceutical manufacturing.
• Direct experience with investigations and root cause analysis in pharmaceutical or medical device products.
• Deep knowledge of current Good Manufacturing Practices and aseptic pharmaceutical manufacturing standards. Understanding of United States Pharmacopeia (USP), European Pharmacopeia (EP), American Chemical Society (ACS).
• Demonstrated success in managing regulatory inspections and Health Authority audits, including strategy and response.
• Ability to influence cross-functional teams and drive a culture of quality and continuous improvement.

Desirable Requirements

• Experience in advanced therapies such as Cell and Gene Therapy and Radioligand Therapy.
• Experience with process improvement: Lean, Six Sigma, and Five S workplace organization (5S).

The salary for this position is expected to range between $138,600 and $257,400 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
$138,600.00 - $257,400.00

Skills Desired
Audit Management, Communication Skills, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Employee Performance Evaluations, Gmp Procedures, Inspection Readiness, Organizational Skills, People Management, People Management and Leadership, Product Release, Qa (Quality Assurance), Self-Awareness, Technological Expertise