Manager/ QA Associate, GxP Quality Systems

Ionis Pharmaceuticals, Inc.; Carlsbad (CA); On-site; USD 70,844 - 102,371; Full time

Benefits offered by this job

Benefits package

Job summary

Ionis Pharmaceuticals, Inc. in Carlsbad, CA is hiring a Manager / QA Associate, GxP Quality Systems to support compliance across Ionis quality systems and ensure GMP/GxP alignment with regulatory requirements.

You will generate QMS metrics, lead cross-functional initiatives, and assist with inspections and vendor audits while contributing to a culture of scientific excellence.

The role offers competitive pay and benefits, with onsite work options and a commitment to innovation in RNA therapies.

Qualifications

• 3+ years of experience in QA within pharma/biotech.
• Strong understanding of GMP/GxP and quality systems.
• Familiarity with QA concepts and regulatory requirements.

Responsibilities

• Support planning, execution, and oversight of GMP and GxP QA activities.
• Ensure alignment with regulatory requirements and Ionis quality management system procedures.
• Generate and present QMS metrics to stakeholders.
• Lead cross-functional initiatives to improve quality system compliance and inspection readiness.
• Assist in vendor management, internal audits, and quality initiatives.

Skills

Quality management

Quality assurance

Communication skills

Cross-functional collaboration

Education

Bachelor’s degree in science or related discipline

Job description

Manager/ QA Associate, GxP Quality Systems

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/ QA ASSOCIATE, GxP QUALITY SYSTEMS

SUMMARY:

Ionis is seeking a Manager / QA Associate, GxP Quality Systems, to support compliance across Ionis quality systems. This role is responsible for supporting the planning, execution, and oversight of GMP and GxP quality assurance activities and ensuring alignment with applicable domestic and international regulatory requirements, industry guidelines, and Ionis quality management system procedures.

CORE RESPONSIBILITIES:

• Support QMS processes and workflows to ensure procedures, records, and practices remain aligned with applicable regulatory requirements, GMP and GxP expectations, and Ionis policies and SOPs.
• Generate, trend, and present QMS metrics to management and cross-functional stakeholders; identify compliance risks, performance gaps, and continuous improvement opportunities.
• Lead and participate in cross-functional initiatives that strengthen quality system compliance, effectiveness, inspection readiness, and operational efficiency.
• Support Quality Management Review activities, including data collection and analysis, development of presentation materials, facilitation support, documentation of actions, and follow-up on commitments.
• Support inspection readiness activities, including coordination of preparation efforts, review of inspection support materials, response tracking, and follow-up on regulatory commitments.
• Support execution of the vendor management program, including supplier, CMO, and CTL audit support, internal audit activities, and vendor change notifications.
• Support new quality initiatives and company-wide projects that require significant QA partnership and resources.
• Contribute to the design and implementation of corporate quality and continuous improvement programs.

REQUIREMENTS:

• Bachelor’s degree in a science-related or other relevant discipline required.
• Strong understanding of quality assurance and quality management, with 3+ years of relevant experience required.
• Strong understanding of quality systems guidelines and regulatory requirements applicable to the pharmaceutical or biotechnology industry required.
• Familiarity with artificial intelligence applications in a GxP quality assurance or quality systems environment is highly desirable.
• Strong customer orientation, written and verbal communication skills, and pragmatic problem-solving skills required.

Ionis offers an excellent benefits package!

The pay scale for this position is $70,844 to $102,371

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.