Manager/Senior Manager, GMP Quality - Drug Substance

Manager/Senior Manager, GMP Quality - Drug Substance

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We're pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We're building on our rich history, and we believe our greatest achievements are ahead of us. If you're passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!

MANAGER/ SENIOR MANAGER, GMP QUALITY - DRUG SUBSTANCE

SUMMARY:

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.

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 decisions.
• 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.

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.