Head Site QA Operations​/Assoc Dir

Job Description Summary

Head of Site QA Operations

Location:

Millburn, NJ, USA
Relocation Support:
Novartis does not offer relocation assistance; apply only if you can work on-site.

Novartis is pioneering Radioligand Therapy (RLT), a fusion of nuclear medicine and precision oncology. As we expand our global RLT manufacturing footprint, we need a passionate, purpose‑driven leader to oversee quality assurance for Production, Quality Control, and Quality Engineering/Validation. You will foster a culture of excellence and ensure compliance that safeguards patient trust.

• Lead and inspire the Site QA Operations team across QA Shop Floor, Batch Release, and Engineering, fostering excellence and accountability.
• Serve 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, set readiness strategies and guide teams through responses.
• Build and mentor future leaders, promoting collaboration and a strong quality culture throughout the organization.

• Bachelor’s degree in Chemistry, Biology, Pharmacy, Biochemistry, Engineering, or related field; advanced degree preferred.
• Minimum 10 years of experience in Quality Assurance or related GxP areas within pharmaceutical or medical device industries.
• Proven track record of leading a QA 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, USP, EP, and ACS standards for aseptic manufacturing.
• Demonstrated success in managing regulatory inspections, strategy, and response.
• Ability to influence cross‑functional teams and drive a culture of quality and continuous improvement.

• 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.

$138,600 – $257,400 per year (performance‑based cash incentive, eligibility for annual equity awards, and a comprehensive benefits package).

• Audit Management
• Communication Skills
• Continued Learning
• Decision Making Skills
• Employee Performance Evaluations
• GMP Procedures
• Inspection Readiness
• Organizational Skills
• People Management and Leadership
• Product Release
• Quality Assurance
• Self‑Awareness
• Technological Expertise

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.

Novartis is committed to providing reasonable accommodations for individuals with disabilities. If you need an accommodation for any part of the application process or to perform the essential functions of the position, please email us.reasonab or call +1(877)395‑2339 and include the job requisition number in your message.