Manager, Senior Manager – Development Quality Assurance

Ionis Pharmaceuticals, Inc.

. Provide quality oversight and support for creation, revision, review, approval, periodic review, and retirement of Development controlled documents within Veeva Quality .

Posted 9/18/2026full-timeRemote • United StatesSenior💰 $77,218 - $130,560 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in GCP Quality Assurance, including document quality reviews, audit support, and QMS process management. Proficient in using Veeva Quality and electronic QMS platforms to ensure compliance with regulatory standards and improve quality management systems.

Highest-signal resume keywords

GCP Quality AssuranceVeeva QualityDocument Quality ReviewsClinical Development ProcessAudit Support

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GCP Regulatory RequirementsQuality Management PrinciplesSOP Writing and ReviewControlled Document Lifecycle ManagementQMS Metrics Analysis

Soft Skills

Effective CommunicationInterpersonal SkillsOrganizational SkillsTime ManagementCustomer Service Orientation

Tools & Technologies

Electronic QMS PlatformsAI-Enabled ToolsDigital Tools

Industry Keywords

ICH GuidelinesGxPTMF AuditsHealth Authority InspectionsQuality Oversight

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide quality oversight and support for creation, revision, review, approval, periodic review, and retirement of Development controlled documents within Veeva Quality
Perform document quality reviews for consistency, clarity, regulatory compliance, and adherence to Ionis standards
Guide Development stakeholders on controlled document requirements, workflows, templates, and lifecycle activities
Support management and continuous improvement of Development QMS processes and associated tools
Author or revise Development QA procedures, templates, and tools
Support deviations, CAPAs, and effectiveness checks
Monitor, analyze, and report Development QMS metrics and trends
Prepare periodic QMS reports and materials for biannual quality management review meetings
Identify recurring trends, systemic risks, and opportunities for process and QMS improvement
Partner with stakeholders and leadership to resolve quality issues
Conduct CSR, TMF, and other GCP-related audits as assigned
Review audit reports, responses, corrective actions, and CAPAs
Support planning, preparation, conduct, and follow-up of global Health Authority inspections
Remain current on regulations, regulatory intelligence, and potential impact
Use approved company technology, including AI-enabled and digital tools, with appropriate human oversight

Requirements

What you’ll need

Bachelor’s degree with a minimum of 5 years of GCP quality assurance experience, or an equivalent combination of education and experience
Healthcare or scientific-related discipline preferred
Strong working knowledge of the clinical development process, ICH Guidelines, applicable global GCP regulatory requirements, and quality management principles
Knowledge of other GxP areas, such as GVP, a plus
Experience writing and reviewing SOPs supporting clinical research highly desirable
Experience conducting or supporting GCP audits, document audits, and TMF audits
Experience with electronic QMS platforms; Veeva Quality preferred
Experience managing controlled document lifecycle activities and performing document quality reviews
Demonstrated attention to detail and commitment to high-quality deliverables while meeting deadlines and commitments
Effective verbal and written communication skills
Effective interpersonal skills and ability to work collaboratively as a team player
Organizational and time management skills
Ability to collaborate effectively with cross-functional teams across geographies
Strong customer service orientation
Ability to manage multiple projects in a dynamic environment and meet accelerated timelines
Ability to travel as business needs require, including on short notice when needed

Benefits

Comp & perks

Excellent benefits package
Onsite, hybrid, and remote work environments
Reasonable accommodation for applicants with disabilities