Manager/Senior Manager, GMP Quality - Drug Substance

Ionis-Pharmaceuticals; Carlsbad (CA); On-site; USD 71,000 - 127,000; Full time

Benefits offered by this job

Benefits package

Job summary

Ionis Pharmaceuticals in Carlsbad, CA seeks a Manager/Senior Manager, GMP Quality - Drug Substance to provide QA leadership across internal and external DS manufacturing and testing. Reference is made to phase-appropriate compliance, QMS processes, and collaboration with CMOs/CDMOs.

The role emphasizes supporting regulatory inspections, document reviews and cross-functional partnership to ensure product quality and compliance.

Qualifications

• Bachelors in Chemistry, Biological Sciences, Engineering or related field.
• Strong analytical, technical and critical-thinking abilities.
• Excellent written and verbal communication skills.

Responsibilities

• Lead GMP Quality Assurance activities for Drug Substance manufacturing, testing and release.
• Provide QA oversight for clinical and commercial programs with risk-based focus.
• Support QMS processes: deviations, CAPAs, change control, investigations, and validation.
• Collaborate with CMOs/CDMOs and review manufacturing/analytical documentation.
• Assist in regulatory inspections and partner audits; ensure compliance.

Skills

Analytical skills

Communication skills

Critical thinking

Education

Bachelor’s degree in Chemistry/Biological Sciences/Engineering

Tools

SAP

Veeva

Job description

Manager/Senior Manager, GMP Quality - Drug Substance

Job Category: Development - Ionis

Requisition Number: IONIS004115

• Full-Time

Locations

Showing 1 location

Carlsbad, CA 92010, USA

Description

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.

WORK LOCATION: Onsite in Carlsbad, CA

CORE RESPONSIBILITIES:

• Lead and manage GMP Quality Assurance activities supporting internal and external Drug Substance and Intermediate manufacturing, testing, and release.
• Senior Manager: 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.
• Oversee, and/or support 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 Quality assurance interface for contract manufacturing and testing organizations (CMOs), including review and approval of manufacturing documentation, analytical data, deviations, changes, and validation packages.
• Support and/or participate in real-time QA 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.
• Support 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.
• Support 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 experience in 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
• knowledge of global cGMP regulations (FDA, EMA, ICH, etc.).
• SAP and Veeva systems experience
• Strong analytical, technical, and critical-thinking skills.
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities and adapt to changing business needs.

Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits

The pay scale for this position is $70,844 to $126,585
The pay scale for the Manager position is $70,844 to $102,371
The pay scale for the Senior Manager position is $87,530 to $126,585

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.

Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.