Manager/Senior Manager, GMP Quality - Drug Substance

Ionis Pharmaceuticals, Inc.•Carlsbad, CA

48d•$70,844 - $126,585•Hybrid

About The Position

Ionis is seeking an experienced Manager/ Senior Manager, GMP Quality - Drug Substance to provide Quality Assurance activities supporting both clinical and commercial Drug Substance (DS) manufacturing and testing. This role provides strategic leadership, operational oversight, and hands-on QA expertise across internal operations and external manufacturing partners. Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.

Requirements

Bachelor’s degree in Chemistry, Biological Sciences, Engineering, or a related discipline
At least 5 years of pharmaceutical industry experience, including Quality Assurance within a cGMP environment
Demonstrated experience supporting Drug Substance manufacturing across both clinical; limited commercial experience is a plus but not required.
Experience working with CMOs/CDMOs, including oversight of manufacturing, testing, and release activities
Working 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.
Excellent written and verbal communication skills.
Ability to manage multiple priorities and adapt to changing business needs.

Nice To Haves

limited commercial experience is a plus but not required.

Responsibilities

Lead and manage GMP Quality Assurance activities supporting internal and external Drug Substance and Intermediate manufacturing, testing, and release.
Senior Manager-level candidates are expected to demonstrate broader strategic leadership, lead complex cross-functional quality initiatives, influence quality systems and operational strategy, and independently manage regulatory inspection activities and high-risk quality decision
Provide QA oversight across clinical and commercial programs, ensuring phase-appropriate compliance and inspection readiness.
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.
Serve as the QA interface for contract manufacturing and testing organizations (CMOs), including review and approval of manufacturing documentation, analytical data, deviations, changes, and validation packages.
Provide real-time QA support and risk-based decision-making during critical manufacturing operations
Support and lead regulatory inspections, partner audits, and Qualified Person (QP) interactions.
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.
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.
Drive new quality initiatives and cross-functional projects.
Apply strong cGMP knowledge in daily activities.
Perform additional duties as assigned.