ASSISTANT/ASSOCIATE DIRECTOR, PHARMACOVIGILANCE QASUMMARY: We are seeking a highly motivated individual to join as an Assistant/Associate Director, Pharmacovigilance Quality Assurance. This is a hands-on QA role within Development Quality Assurance that supports the execution of a risk-based GVP quality program. This role partners closely with Patient Safety and Pharmacovigilance, Clinical Operations, Clinical Development, Regulatory Affairs, Medical Affairs, GMP QA, business partners, and service providers to support audit execution, inspection readiness, PV quality systems support, service provider oversight, metrics, and continuous improvement activities, in alignment with Ionis PV QA expectations.
WORK LOCATION: remote US-based; at least 10-15% travel
CORE RESPONSIBILITIESGVP Audit Program
- Support implementation and maintenance of a comprehensive, 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, including audit preparation, execution, reporting, CAPA follow-up, and closure.
- Prepare and/or review timely, well-written audit reports and communicate findings to auditees, cross-functional representatives, and management.
- Assess and review audit responses to ensure CAPA plans adequately address findings and root causes, including effectiveness checks where appropriate, and maintain, track, and follow up on CAPAs through completion.
- Develop, review, and/or revise audit plans, SOPs, guidance documents, templates, and related documents supporting PV QA activities.
Audit and Inspection Readiness
- Support PV inspection readiness activities and participate in regulatory authority inspections, partner audits, and other external assessments impacting PV systems and processes.
- Lead and/or contribute to the assessment of Health Authority inspection and PV partner audit reports and results, including associated risks and recommendations, for communication to relevant leadership.
- Provide PV QA guidance and training to internal stakeholders involved in clinical development, patient safety, and other applicable functions involved in PV audit and inspection activities, including clinical trial safety processes and GCP/GVP interfaces
- Monitor relevant GVP regulatory intelligence and support assessment and implementation of new or revised requirements affecting clinical trial safety processes, systems, and service providers.
Functional Quality Support
- Provide quality support to Patient Safety and Pharmacovigilance, Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, and other applicable functions on PV and clinical trial safety quality matters.
- Provide quality oversight and quality input for PASS-related activities, including support for quality planning, issue escalation, vendor oversight, and inspection readiness, as applicable.
- Provide QA input to PV-related deviations, CAPAs, change controls, investigations, and other quality events, and escalate significant compliance risks to management as appropriate.
- Provide QA oversight support for PV and PV-related service providers across their lifecycle, including qualification support, agreement review, governance support, and risk-based oversight activities as applicable.
- Support development, maintenance, and communication of PV QA metrics and dashboards to enable management oversight, trend evaluation, and proactive risk management.
- Mentor, support, and/or manage the activities of internal and external Development QA personnel.
- Support cross-GxP QA activities requiring PV expertise, as requested.
- Maintain effective organization, documentation, and communication practices to ensure timely execution of assigned responsibilities and sustained inspection readiness.
- 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:- For the Assistant Director role, a bachelor's degree with a minimum of 8 years, a master's degree with a minimum of 6 years, a PhD with a minimum of 3 years: for the Associate Director a bachelor's degree with a minimum of 12 years, a master's degree with a minimum of 8 years, a PhD with a minimum of 5 years of GVP quality assurance or relevant clinical trial safety experience within the pharmaceutical and biotechnology industry and/or service provider work experience is required; a healthcare/scientific-related discipline is highly desirable.
- Strong GVP auditing and clinical safety experience required, 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, applicable health authority guidance, and ICH guidelines.
- Experience supporting or participating in global regulatory inspections, partner audits and inspection-readiness activities.
- Good understanding of the clinical development process, risk-based quality systems approaches, clinical PV and post-market PV activities.
- Experience writing, reviewing, and revising SOPs and other controlled documents supporting PV activities.
- Experience with PV-related 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 is preferred.
- Strong interpersonal, verbal, and written communication skills, with the ability to work effectively across functions and influence without direct authority.
- Strong organizational and time management skills, with the ability to manage multiple priorities in a dynamic environment.
- Ability to travel and as business needs require, including on short notice when needed.
Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS004096
Ionis offers an excellent benefits package! Follow this link for more details:
Ionis BenefitsFull Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits
The pay scale for this position is $121,205 to $196,548
The pay scale for the Assistant Director position is $121,205 to $162,726
The pay scale for the Associate Director position is $138,908 to $196,548
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
