Ionis Pharmaceuticals, Inc. · 14 hours ago
Assistant Director/Associate Director, GMP Quality – Drug Substance (Clinical & Commercial)
Carlsbad, CA
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$102K/yr - $148K/yr
10+ years expIonis Pharmaceuticals, Inc. is a company headquartered in Carlsbad, California, specializing in RNA-targeted medicines. They are seeking an experienced Assistant Director/Associate Director, GMP Quality – Drug Substance to lead and oversee Quality Assurance activities supporting both clinical and commercial Drug Substance manufacturing and testing.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Lead and manage GMP Quality Assurance activities supporting internal and external Drug Substance and Intermediate manufacturing, testing, and release
May manage, mentor, and develop QA staff and/or provide functional leadership to matrixed teams, depending on organizational needs
Provide QA oversight across clinical and commercial programs, ensuring phase-appropriate compliance and inspection readiness
Drive continuous improvement initiatives to enhance compliance, efficiency, and product quality
Collaborate cross-functionally with Technical Operations, CMC, Regulatory, Clinical, Supply Chain, and IT teams. Communicate quality- or supply-impacting issues clearly to internal and external stakeholders
Oversee and execute core Quality Management System (QMS) processes, including batch record review, deviations, investigations, CAPAs, change control, OOS/OOT management, risk management, validation, and training compliance
Review and approve technical and quality documentation, including validation reports, stability data, and APQR/QMR inputs
Utilize enterprise quality systems, including SAP and Veeva, to support compliant and efficient quality operations
Serve as the primary QA interface for contract manufacturing and testing organizations (CMOs), including review and approval of manufacturing documentation, analytical data, deviations, changes, and validation packages
Participate in real-time QA decision-making during critical manufacturing operations
Support and lead regulatory inspections, partner audits, and Qualified Person (QP) interactions
Support new quality initiatives and cross-functional projects
Apply strong cGMP knowledge in daily activities
Perform additional duties as assigned
Qualification
Required
Bachelor's degree in Chemistry, Biological Sciences, Engineering, or a related discipline (advanced degree preferred)
10–12+ years of pharmaceutical industry experience, including 7–8+ years in Quality Assurance within a cGMP environment
Demonstrated experience supporting Drug Substance manufacturing across both clinical and commercial stages
Strong knowledge of global cGMP regulations (FDA, EMA, ICH, etc.)
Excellent written and verbal communication skills
Ability to manage multiple priorities and adapt to changing business needs
Preferred
Advanced degree in Chemistry, Biological Sciences, Engineering, or a related discipline
Experience with SAP and Veeva systems is highly desired
Strong analytical, technical, and critical-thinking skills with experience in manufacturing
Benefits
Ionis offers an excellent benefits package!
Company
Ionis Pharmaceuticals, Inc.
For three decades, Ionis has invented medicines that bring better futures to people with serious diseases.
501-1000 employees
H1B Sponsorship
Ionis Pharmaceuticals, Inc. 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 (8)
2024 (5)
2023 (3)
2022 (5)
2021 (5)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$2.45B2025-11-13Post Ipo Debt· $700M
2024-09-09Post Ipo Equity· $500.3M
2023-06-06Post Ipo Debt· $500M
Leadership Team
Brett P. Monia
Chief Executive Officer
Eric Bastings
Senior Vice President, Development Strategy
Recent News
Labiotech UG
2026-01-22
Business Wire
2026-01-22
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