Manager – Development Quality Assurance

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and support the quality assurance of the creation, revision, review, approval, periodic review, and retirement of Development controlled documents within Veeva Quality.

• Conduct document quality assessments to ensure consistency, clarity, compliance with relevant regulations, and adherence to Ionis controlled document standards.

• Offer guidance and assistance to Development stakeholders regarding controlled document requirements, workflows, templates, and lifecycle activities.

• Aid in the management and continuous enhancement of Development QMS processes and related templates/tools.

• Author and revise Development QA procedures, templates, and tools as assigned.

• Assist Development stakeholders with deviations, CAPAs, effectiveness checks, and other QMS-related activities.

• Track, analyze, and report on 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 improvements.

• Collaborate with Development stakeholders and leadership to ensure 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.

• Assist in the planning, preparation, execution, and follow-up of global Health Authority inspections.

• Stay updated on new and revised regulations and regulatory intelligence.

• Utilize approved company technology, including AI-enabled and digital tools where appropriate, with the necessary human oversight.

⛳️ Requirements

• Bachelor’s degree with at least 5 years of experience in GCP quality assurance or an equivalent combination of education and experience.

• A background in healthcare or a scientific discipline is preferred.

• Strong understanding of the clinical development process, ICH Guidelines, applicable global GCP regulatory requirements, and quality management principles.

• Knowledge of additional GxP areas (e.g., GVP) is a plus.

• Experience in writing and reviewing SOPs that support clinical research is highly desirable.

• Proven experience conducting or supporting GCP audits, document, and TMF audits.

• Familiarity with electronic QMS platforms; experience with Veeva Quality is preferred.

• Proven experience managing controlled document lifecycle activities and performing document quality reviews.

• Strong attention to detail and a commitment to delivering high-quality outputs while meeting deadlines and commitments.

• Excellent verbal and written communication skills.

• Strong interpersonal skills, with the ability to work collaboratively as a team player while remaining flexible without compromising quality.

• Effective organizational and time management skills.

• Ability to collaborate effectively with cross-functional teams across different locations to achieve shared objectives.

• Strong customer service orientation.

• Capability to manage multiple projects in a dynamic environment and meet accelerated timelines.

• Willingness to travel as business needs arise, including on short notice when necessary.

🏝️ Benefits

• Comprehensive benefits package.

• Highly competitive benefits.