Manager – Development Quality Assurance

Ionis Pharmaceuticals, Inc.

. Provide quality oversight and support for the 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 collaborating with cross-functional teams to ensure compliance with regulatory requirements and continuous improvement of quality systems.

Highest-signal resume keywords

GCP Quality Assurance ExperienceDocument Quality ReviewsVeeva Quality ExperienceClinical Development Process KnowledgeSOP Writing and Review

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GCP Regulatory RequirementsQuality Management PrinciplesControlled Document Lifecycle ManagementQMS Metrics AnalysisAudit Conducting and SupportCAPA ManagementDeviation ManagementSOP DevelopmentTMF AuditsElectronic QMS Platforms

Soft Skills

Effective Communication SkillsInterpersonal SkillsOrganizational SkillsTime Management SkillsCustomer Service Orientation

Tools & Technologies

Veeva QualityAI-Enabled ToolsDigital Tools

Industry Keywords

ICH GuidelinesGxPHealthcareScientific DisciplineQuality Oversight

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide quality oversight and support for the creation, revision, review, approval, periodic review, and retirement of Development controlled documents within Veeva Quality
Perform document quality reviews to promote consistency, clarity, compliance with applicable requirements, and adherence to Ionis controlled document standards
Provide guidance and support to Development stakeholders regarding controlled document requirements, workflows, templates, and lifecycle activities
Support management and continuous improvement of Development QMS processes and associated templates/tools
Author/revise Development QA procedures, templates, and tools as assigned
Support Development stakeholders with deviations, CAPAs, effectiveness checks, and other QMS activities
Monitor, analyze, and report Development QMS metrics and trends
Prepare periodic QMS reports, metrics, analyses, and supporting materials for biannual QMR meetings
Identify recurring trends, potential systemic risks, and opportunities for process and QMS improvement
Partner with Development stakeholders and leadership to support timely and effective resolution of identified quality issues
Conduct CSR and/or TMF audits and other GCP-related audits as assigned
Review audit reports and related responses, corrective actions, and CAPAs
Support planning, preparation, conduct, and follow-up of global Health Authority inspections
Remain current on new and revised regulations and regulatory intelligence
Use approved company technology, including AI-enabled and digital tools where appropriate, 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 is 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 (e.g., GVP) a plus
Experience writing and reviewing SOPs that support clinical research is highly desirable
Experience conducting or supporting GCP audits, document, and TMF audits
Experience with electronic QMS platforms; experience with Veeva Quality is 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, with the ability to work collaboratively as a team player while remaining flexible without compromising quality
Organizational and time management skills
Ability to collaborate effectively with cross-functional teams across geographies to achieve shared objectives
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
Highly competitive benefits