Novartis · 4 hours ago
Head, Quality Control
Durham, NC
Full-time
Onsite
Director/Executive
$139K/yr - $257K/yr
10+ years expNovartis is seeking an experienced Head of Quality Control to provide strategic and operational leadership for QC laboratories supporting Drug Substance, Drug Product, and Finished Product manufacturing. This role involves designing and implementing compliant testing strategies while building a scalable QC organization for clinical and commercial manufacturing.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Develops and executes corporate quality policies, practices, procedures, standards, and systems necessary to ensure adherence to DS/DP/FP production and product management in accordance with the cGxP compliance to U.S. and EU regulations
Oversees the testing and validation strategy, with a concentrated focus on method verification and validation
Maintains a robust Environmental Monitoring program that meets U.S./EU and other applicable regulatory requirements
Organizes and directs cross functional relationships with Manufacturing, Engineering, MS&T, Quality Assurance, and Regulatory
Build, lead, and develop QC laboratory teams by hiring and mentoring staff, setting performance expectations, manage external contract vendors, and ensuring efficient utilization of laboratory resources
Authors and approve documents required for regulatory submissions
Develops, implements, and ensures laboratory procedures and policies are followed
Provides presentations, explain laboratory qualification and operations, and defend testing results during FDA and other inspections
Other duties for which QC is responsible, as assigned
Qualification
Required
BS or MS in Chemistry, Pharmacy, or a related natural science with a minimum of 10 years of experience in a cGMP laboratory environment
Deep working knowledge of U.S. and EU regulatory requirements, including USP and European Pharmacopoeia standards
Minimum of 6 years of people and laboratory management experience
Prior proven experience leading operational quality control organizations
Demonstrated experience establishing startup lab facilities supporting clinical and/or commercial manufacturing
Direct experience supporting and leading regulatory agency inspections
Fluency in English (written and verbal)
Preferred
PhD in life sciences
Benefits
Health, life and disability benefits
A 401(k) with company contribution and match
A 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
2026-01-23
2026-01-23
Company data provided by crunchbase