Ph3Overview /h3pOur 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. /ph3Responsibilities /h3ulliProvide global quality oversight for the pharmacovigilance system and the quality management system. /liliDeliver expert guidance on bGVP /b and bGCP /b regulatory expectations, including bFDA /b, bEMA /b, and bICH /b guidelines. /liliReview and ensure compliance for pharmacovigilance outputs such as bICSRs /b, bDSURs /b, bRMPs /b, and bREMS /b. /liliManage vendor and partner oversight to ensure consistent and compliant delivery of delegated bGCP /b and bGVP /b activities. /liliLead deviation management processes, including root cause analysis and the tracking of bCAPA /b effectiveness. /liliHost and support regulatory inspections and audits by developing and implementing remediation plans. /liliCollaborate with cross-functional teams to drive quality process improvement initiatives and ensure inspection readiness. /li /ulh3Qualifications /h3ulliYou have a Bachelor’s degree in Life Sciences, Science, or Engineering. /liliYou bring 8+ years of experience in bGVP /b, bGCP /b, and bpharmacovigilance /b within the pharmaceutical or biotech industry. /liliYou possess extensive experience in quality assurance, including bCAPA /b, bdeviation management /b, and baudit /b activities. /liliYou have a demonstrated history of supporting global regulatory inspections and managing bGVP /b quality systems. /liliYou bring strong analytical, problem-solving, and communication skills with a focus on ethical standards. /liliYou are fluent in bEnglish /b. /li /ulh3Nice to Haves /h3ulliExperience with bVeeva Systems /b or the bArgus /b global safety database. /liliPossession of a Master’s degree in a relevant scientific field. /li /ul /p #J-18808-Ljbffr