Novartis · 9 hours ago
Head, QA Ops and Compliance
Durham, NC
Full-time
Onsite
Director/Executive
$139K/yr - $257K/yr
10+ years expNovartis is a leading global healthcare company, and they are seeking a Head, QA Ops and Compliance to provide strategic and hands-on leadership for Quality Assurance within the Small Molecule Operations division. This role is pivotal in ensuring compliance with cGMP standards and overseeing quality operations to support the supply of high-quality therapies.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Provide end-to-end leadership for Quality Operations and Compliance across manufacturing, Quality Control, AS&T, and logistics, ensuring adherence to cGMP, regulatory requirements, and internal quality standards
Serve as the final QA authority for review, approval, and release of batch documentation and patient or commercial product lots manufactured at the site
Ensure strong on-the-floor QA presence, delivering real-time quality oversight, decision-making, and guidance to support compliant and efficient operations
Lead investigations of deviations, OOX/OOS events, complaints, and adverse events, ensuring timely root cause analysis, effective CAPA implementation, and sustainable corrective actions
Implement and maintain site Quality Systems, including SOP governance, training compliance, documentation control, and inspection readiness for internal, external, and regulatory audits
Drive QA Operational Excellence through performance metrics (KPIs/KQIs), continuous improvement initiatives, and proactive identification of quality and process risks
Provide QA leadership for technology transfers, process validation, and new equipment commissioning, including review and approval of validation strategies and OQ/PQ execution
Lead, develop, and retain a high-performing QA team through hiring, coaching, performance management, and resource planning, while supporting budget and capacity planning in alignment with site strategy
Qualification
Required
BS or MS in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related scientific discipline; advanced degree preferred
Minimum 10+ years of experience in pharmaceutical, biotechnology, or cell and gene therapy industry within cGMP regulated environments
Demonstrated experience in Quality Operations and/or Quality Systems & Compliance leadership roles, with direct responsibility for product release, quality systems, and audit readiness
Minimum 6-10 years of direct people leadership, including team development, performance management, and cross-functional collaboration
Strong working knowledge of FDA, EMA, and global regulatory requirements, including experience supporting regulatory inspections and audits
Proven experience leading deviation investigations, CAPA management, and continuous improvement initiatives in an operational QA setting
Experience supporting manufacturing operations, Quality Control, validation, and technology transfer activities
Excellent communication, decision-making, and organizational skills, with the ability to operate effectively in a fast-paced CGT manufacturing environment
Fluency in English (written and verbal)
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
2026-02-06
2026-02-06
Longevity.Technology
2026-02-06
Company data provided by crunchbase