Manager​/Senior Manager, Development Quality Assurance

Job Category
:
Development - Ionis

Requisition Number
: IONIS
004134

• Posted :
  September 18, 2026
• Full-Time

Showing 1 location

Remote
United States

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!

We are seeking a highly motivated and experienced quality professional to join our team as a Manager/Senior Manager, Development Quality Assurance. This position provides quality oversight and support for the management of controlled documents within the Veeva quality management system (QMS), including document quality review and lifecycle activities, to promote compliance with applicable global regulations, guidelines, and Ionis procedures and standards.

The Manager/Senior Manager will support Development stakeholders by providing guidance for deviations, corrective and preventive actions (CAPAs), effectiveness checks, and other QMS activities. This role is also responsible for monitoring and reporting monthly Development QMS metrics and preparing QMS metrics for the bi-annual quality management review meeting (QMR). This position will perform document audits (e.g., clinical study reports (CSRs)) and trial master file (TMF) audits.

The individual may also support with the planning, preparation, conduct and follow-up of global Health Authority (HA) inspections and perform other Development Quality Assurance responsibilities as assigned.

Remote

• Provide quality oversight and support for the creation, revision, review, approval, periodic review, and retirement of Development controlled documents within Veeva Quality, in collaboration with Document Control.
• Perform document quality reviews to promote consistency, clarity, compliance with applicable requirements, and adherence to Ionis controlled documents standards.
• Provide guidance and support to Development stakeholders regarding controlled document requirements, workflows, templates, and lifecycle activities.
• Support the management and continuous improvement of Development…