Novartis · 1 day ago
Head Site QA Operations/Assoc Dir
Millburn, NJ
Full-time
Onsite
Director/Executive
$139K/yr - $257K/yr
10+ years expNovartis is pioneering the future of cancer treatment through Radioligand Therapy (RLT). As the Head of Site QA Operations, you will lead quality oversight for Production, Quality Control testing, and Quality Engineering/Validation, fostering a culture of excellence and ensuring compliance that safeguards patient trust.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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
Qualification
Required
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
Preferred
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)
Benefits
Health, life and disability benefits
401(k) with company contribution and match
Generous time off package including vacation, personal days, holidays and other leaves
Company
Novartis
Novartis is a pharmaceutical company that researches and develops medicines for serious diseases to improve and extend people's lives.
10001+ employees
H1B Sponsorship
Novartis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (27)
2023 (23)
2022 (27)
2021 (31)
2020 (25)
Funding
Current Stage
Public CompanyTotal Funding
$2.49BKey Investors
Bill & Melinda Gates Foundation
2024-06-19Post Ipo Debt· $2.49B
2018-02-14Grant· $6.5M
2000-05-19IPO
Leadership Team
Daniel Grant
Vice President & Global Program Head
John von Brachel
VP, Head of Content Lab
Recent News
2026-01-11
Morningstar.com
2026-01-11
Company data provided by crunchbase