Job 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