Manager/ Senior 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/ SENIOR QA ASSOCIATE, GxP QUALITY SYSTEMS

SUMMARY: 

Ionis is seeking a Manager / Senior 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.

Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS004063

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

Full Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits

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

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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

Pioneer in RNA-targeted antisense therapeutics, developing treatments for neurological, cardiovascular, and rare diseases. Headquartered in Carlsbad, CA.

ionispharma.com