Assistant Director​/Associate Director, GMP Quality – Drug Substance; Clinical & Commercial

Overview

Headquartered in Carlsbad, California, Ionis has offices in Boston and Dublin. Ionis focuses on RNA-targeted medicines and gene editing to address serious diseases, with a leading pipeline in neurology, cardiology and select areas of high patient need.

Ionis aims to foster a challenging, motivating and rewarding environment that supports innovation and scientific excellence. The company seeks diverse individuals and perspectives and supports onsite, hybrid and remote work environments. If you’re passionate about impacting patients, consider applying to join the team.

Job Summary:

Ionis is 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 (DS) manufacturing and testing. This role provides strategic quality leadership across Ionis’ Drug Substance portfolio, spanning early clinical development through commercial manufacturing.

The successful candidate will serve as a key Quality partner to Technical Operations and external manufacturing and testing organizations, with direct influence on inspection readiness, product supply, and lifecycle execution. This role combines strategic leadership, operational oversight, and hands-on QA expertise across internal operations and external partners and offers high visibility and autonomy to shape quality strategy, support critical manufacturing activities, and drive continuous improvement across the organization.

This is an onsite position.

• 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

• 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.).
• Experience with SAP and Veeva systems is highly desired.
• Strong analytical, technical, and critical-thinking skills with experience in manufacturing is preferred.
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities and adapt to changing business needs.

Please visit our website,  for more information about Ionis and to apply for this position; reference requisition # IONIS
003877.

Ionis offers an excellent benefits package. Full Benefits Link:

The pay scale for this position is: $102,000 to $182,000. The pay scale for the Assistant Director is $102,000 to $148,000. The pay scale for the Associate Director is $139,000 to $182,000.

NO PHONE CALLS PLEASE. PRINCIPALS ONLY. Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.