Manager/ Senior Manager, Development Quality Assurance

Ionis Pharmaceuticals, Inc.

Carlsbad (CA)

Remote

USD 77,000 - 131,000

Full time

5 days ago

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Benefits offered by this job

Health benefits

Remote work options

Job summary

Ionis Pharmaceuticals, Inc. seeks a Manager/Senior Manager, Development Quality Assurance to oversee Development controlled documents within Veeva QMS and to guide deviations, CAPAs, and QMS activities.

You will monitor metrics, prepare QMR materials, and support inspections in a fast-paced biotech setting. The role emphasizes quality oversight, document lifecycle management, and cross-functional collaboration with Development teams across geographies.

Qualifications

Bachelor’s degree with at least 5 years of GCP QA experience.
Knowledge of ICH/GCP requirements and GxP principles.
Experience with Veeva Quality or similar QMS platforms.

Responsibilities

Provide quality oversight for Development controlled documents in Veeva Quality.
Perform document quality reviews for clarity and compliance with requirements.
Support deviations, CAPAs, effectiveness checks, and QMS processes.
Monitor Development QMS metrics and prepare QMS reports for QMR meetings.
Conduct CSR and TMF audits and support related audits.
Assist with Health Authority inspections as assigned.

Skills

GCP QA

ICH Guidelines

SOP Writing

GxP Knowledge

Audit Experience

Team Collaboration

Education

Bachelor's degree

Tools

Veeva QMS

Electronic QMS

Job description

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 make a meaningful impact on patients and to join us. Experience and contribute to our unique culture while you develop and expand your career!

MANAGER / SENIOR MANAGER, DEVELOPMENT QUALITY ASSURANCE

Summary

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.

WORK LOCATION

Remote

Responsibilities

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 QMS processes and associated templates/tools.
Author/revise Development QA procedures/templates/tools as assigned
Support Development stakeholders with deviations, CAPAs, effectiveness checks as needed.

QMS Metrics And Quality Management Review (QMR)

Monitor, analyze, and report Development QMS metrics and trends, including deviations, CAPAs, effectiveness checks, controlled documents, and other applicable quality indicators.
Prepare periodic QMS reports and metrics, analyses, and supporting materials for biannual QMR meetings, and other meetings as applicable.
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.

Audit Responsibilities

Conduct CSR and/or TMF audits and may conduct other GCP-related audits as assigned.
Review audit reports and related responses, corrective actions, and CAPAs, as applicable.

Health Authority Inspections

Support with the planning, preparation, conduct and follow up of global Health Authority inspections as assigned.

Other

Remain current on new and revised regulations and other regulatory intelligence and potential impact.
Use approved company technology, including AI-enabled and digital tools where appropriate, to support responsibilities efficiently, while ensuring that all outputs are critically reviewed, verified, and finalized through appropriate human oversight consistent with regulatory and company requirements.

Requirements

A bachelor’s degree with a minimum of 5 years of GCP quality assurance experience or an equivalent combination of education and experience is required. 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 lifestyle 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 while encouraging the same in others. 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.