Manager, Senior Manager – Development Quality Assurance

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

📋 Description

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

• Carry out document quality reviews to ensure consistency, clarity, regulatory compliance, and alignment with Ionis standards.

• Advise Development stakeholders on the requirements for controlled documents, workflows, templates, and lifecycle activities.

• Assist in the management and continuous enhancement of Development QMS processes and associated tools.

• Draft or revise Development QA procedures, templates, and tools.

• Provide support for deviations, CAPAs, and effectiveness checks.

• Monitor, analyze, and report on 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 improvements.

• Collaborate with stakeholders and leadership to address quality issues.

• Conduct CSR, TMF, and other GCP-related audits as assigned.

• Review audit reports, responses, corrective actions, and CAPAs.

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

• Stay updated on regulations, regulatory intelligence, and their potential impact.

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

⛳️ Requirements

• Bachelor's degree with at least 5 years of GCP quality assurance experience, or a comparable combination of education and experience.

• Preference for a background in healthcare or a scientific-related discipline.

• In-depth knowledge of the clinical development process, ICH Guidelines, applicable global GCP regulatory requirements, and quality management principles.

• Familiarity with other GxP areas, such as GVP, is advantageous.

• Highly desirable experience in writing and reviewing SOPs that support clinical research.

• Experience in conducting or aiding GCP audits, document audits, and TMF audits.

• Proficient with electronic QMS platforms; Veeva Quality experience preferred.

• Experience managing controlled document lifecycle activities and performing document quality reviews.

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

• Strong verbal and written communication skills.

• Effective interpersonal skills and the ability to work collaboratively as a team player.

• Strong organizational and time management skills.

• Capability to work effectively with cross-functional teams in various locations.

• Strong customer service focus.

• Ability to manage multiple projects in a fast-paced environment and meet tight deadlines.

• Willingness to travel as needed for business, including short-notice travel when required.

🏝️ Benefits

• Comprehensive benefits package.

• Options for onsite, hybrid, and remote work environments.

• Reasonable accommodations available for applicants with disabilities.