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Manager/Senior Manager GVP, Quality Assurance New


Manager/Senior Manager GVP, Quality Assurance New

Job reference

Company Name

Orchard Therapeutics



Industry sector


Job type

Permanent | Full Time


Posted date



DescriptionLocation: London, EnglandReporting to: Senior Director, R&D QualityOrchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases. Created three years ago, it is in an exciting phase where a Good Pharmacovigilance Practice (GVP) Quality Assurance professional can have a real impact on the work and foundations that are being created.This role will report to the Sr Director, R&D Quality located in London, England and will be responsible for providing day-to-day PVG Quality Assurance support to the Orchard Pharmacovigilance (PV) teams and staff involved in activities impacting on PVG.We are seeking a candidate with strong GVP knowledge, audit skills, communication, and facilitation skills, including the ability to manage multiple projects.ResponsibilitiesBeing the PVG QA Compliance Lead supporting operational PV activities.Handles multiple projects and ensuring overall and timely completion of tasks.Leads the development of company risk based PVG audit strategies and manages audit plan execution.Manages and/or leads GVP routine and complex audits including but not limited to internal processes, vendors and business partners.Trains and manages contracts GVP auditors.Works closely with the PV function to provide expert PV compliance information, manage identified issues, and support continuous improvement.Leads PV inspection readiness preparations and/or directly support regulatory agency inspections. Assist in the coordination of response to any findings.Leads intra/inter-departmental teams that support operations (e.g. evaluation of a new regulation).Evaluate, write and/or review operating procedures (e.g. SOPs), and perform other activities in support of an integrated cross-functional quality management system (QMS).RequirementsBA or BS and 8+ years of relevant experience (6+ years of relevant experience with an MS).QA Professional with a minimum of 5 years of PV experienceSubstantial previous work experience.Must have significant GVP audit and compliance experience. Bio-pharmaceutical sponsor experience preferred.Experience with audit management/CAPA management programs.Recognized as an expert resource on a range of GVP compliance topics.Strong verbal and written communication skills and interpersonal skills.Proficient in Microsoft Office suite.Excellent organization skills and project management.Excellent problem-solving skills.Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused entrepreneurial environment.PROFILEBachelor’s Degree required,– Life Sciences, Regulatory Science, Regulatory Compliance, or Drug Development preferred.Certification as a GVP auditor is a plus.Experience and ability to conduct GVP audits both within and outside EU.Job SummaryID: 4713667864Department: ["Quality Assurance"]Type: full time

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London, England, London, EC2V, United Kingdom

  • Ad ID:  14980583
  • Ad Type:  Offered
  • Posted on:  15/07/2020, 02:59
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