Head Site QA Operations/Assoc Dir

Novartis • Millburn, NJ

16h • Onsite

About The Position

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.

Requirements

• Bachelor’s 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.

Nice To Haves

• 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).

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees