Overview Our client, a global biopharmaceutical organization, is seeking an Impact Quality Lead to implement and maintain a proactive approach to pharmacovigilance compliance. This role focuses on ensuring that all pharmacovigilance activities adhere to international regulatory requirements while providing strategic quality leadership across post-marketing programs.
Responsibilities Provide global quality oversight for the pharmacovigilance system and the quality management system.
Deliver expert guidance on GVP and GCP regulatory expectations, including FDA, EMA, and ICH guidelines.
Review and ensure compliance for pharmacovigilance outputs such as ICSRs, DSURs, RMPs, and REMS .
Manage vendor and partner oversight to ensure consistent and compliant delivery of delegated GCP and GVP activities.
Lead deviation management processes, including root cause analysis and the tracking of CAPA effectiveness.
Host and support regulatory inspections and audits by developing and implementing remediation plans.
Collaborate with cross-functional teams to drive quality process improvement initiatives and ensure inspection readiness.
Qualifications You have a Bachelor’s degree in Life Sciences, Science, or Engineering.
You bring 8+ years of experience in GVP, GCP, and pharmacovigilance within the pharmaceutical or biotech industry.
You possess extensive experience in quality assurance, including CAPA, deviation management, and audit activities.
You have a demonstrated history of supporting global regulatory inspections and managing GVP quality systems.
You bring strong analytical, problem-solving, and communication skills with a focus on ethical standards.
You are fluent in English .
Nice to Haves Experience with Veeva Systems or the Argus global safety database.
Possession of a Master’s degree in a relevant scientific field.
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