Associate Director – Pharmacovigilance Quality Assurance

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Ionis Pharmaceuticals, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1989

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Ionis Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering and developing RNA- and DNA-targeted medicines to treat serious diseases. The company leverages oligonucleotide chemistry and genetic insights to advance a pipeline of therapeutics across neurology, cardiometabolic disorders, and other high-need areas, conducting clinical trials and commercial collaborations to deliver medicines to patients. Ionis emphasizes scientific innovation, patient advocacy, and corporate responsibility in its efforts to translate genetic science into transformative therapies.

📋 Description

• Support implementation and maintenance of a risk-based GVP-compliant quality program covering clinical trial safety and post-marketed safety processes • Plan, conduct, and/or support end-to-end GVP audits of service providers, business partners, affiliates, and internal PV processes • Prepare and/or review audit reports and communicate findings to auditees, cross-functional representatives, and management • Assess audit responses and CAPA plans, conduct effectiveness checks, and track CAPAs through completion • Develop, review, and revise audit plans, SOPs, guidance documents, templates, and related PV QA documents • Support PV inspection readiness and participate in regulatory authority inspections, partner audits, and external assessments • Assess Health Authority inspection and PV partner audit reports, risks, and recommendations for leadership communication • Provide PV QA guidance and training to internal stakeholders involved in clinical development, patient safety, and PV audit and inspection activities • Monitor GVP regulatory intelligence and support implementation of revised requirements • Provide quality support across Patient Safety and Pharmacovigilance, Clinical Development, Clinical Operations, Regulatory Affairs, and Medical Affairs • Provide quality oversight and input for PASS-related activities, deviations, CAPAs, change controls, investigations, and other quality events • Provide QA oversight for PV service providers across their lifecycle, including qualification, agreements, governance, and risk-based oversight • Support PV QA metrics and dashboards for management oversight, trend evaluation, and risk management • Mentor, support, and/or manage internal and external Development QA personnel • Support cross-GxP QA activities requiring PV expertise • Maintain organization, documentation, communication, and inspection readiness • Use approved company technology, including AI-enabled and digital tools, with human oversight

🎯 Requirements

• Assistant Director: bachelor’s degree plus minimum 8 years, master’s degree plus minimum 6 years, or PhD plus minimum 3 years of GVP quality assurance or relevant clinical trial safety experience • Associate Director: bachelor’s degree plus minimum 12 years, master’s degree plus minimum 8 years, or PhD plus minimum 5 years of GVP quality assurance or relevant clinical trial safety experience • Experience within the pharmaceutical and biotechnology industry and/or service provider work experience • Healthcare/scientific-related discipline highly desirable • Strong GVP auditing and clinical safety experience, including internal process, business partner, and service provider audits • GCP auditing experience preferred • Working knowledge of international GVP regulations, FDA and EMA pharmacovigilance and clinical trial safety requirements, GCP regulations, health authority guidance, and ICH guidelines • Experience supporting or participating in global regulatory inspections, partner audits, and inspection-readiness activities • Understanding of clinical development, risk-based quality systems, clinical PV, and post-market PV activities • Experience writing, reviewing, and revising SOPs and controlled PV documents • PV service provider oversight, quality agreements, CAPAs, deviations, and change controls preferred • Knowledge of computer system validation and data integrity concepts relevant to GVP/GCP systems preferred • Strong verbal and written communication skills and ability to influence without direct authority • Strong organizational and time management skills with ability to manage multiple priorities • Ability to travel, including on short notice when needed

🏖️ Benefits

• Excellent benefits package • Remote work arrangement • EEO employer