Quality and Compliance Manager (Pharmareview)

Job title:

Quality and Compliance Manager (Pharmareview)

Company

IQVIA

Job description

The Compliance Lead is a senior member of the Quality and Compliance Team responsible for monitoring and maintaining internal compliance in line with External regulations and requirements and internal policies, in order to meet quality expectations.
An escalation point for compliance and Code queries and acts as an Any Qualified Person ( AQP, non-medical signatory) or medical signatory.Responsibilities:
The Compliance Lead at PharmaReview is responsible for:Being a subject matter expert within the group and a source of advice and information to IQVIA staff on quality control processesIdentifying quality and compliance issues, providing solutions and preventative actionsDemonstrating commitment to exploring optimal ways of workingSetting standards for the teamDevelopment, maintenance, and training of Policies, SOPs, Work Instructions. Liaise promptly with process owners / document authors in case of questionsDevelop quality tools such as checklists and quality guidelines.Smartsolve Quality Management System administratorGCP Training Records management in collaboration with Training managerPrimary contact for IQVIA Quality and Compliance TeamCoordinating compliance training with the medical director / training manager including Code Clinic agendas, ‘HOT TOPICs’ and other areas of identified needTake a leading role in providing training, guidance, and mentoring, including standardised measurements to ensure consistency across teams and best practice is adoptedLead role in proposing, developing, evaluating, and implementing process changes and tools and monitoring their adoption and benefitsUnderstanding external client’s compliance needs and ensuring internal policies and activities meet this and vice versa; collaborate with AL for onboarding and EBR on compliance aspectsAct as escalation point for Third Pair of Eyes [TPOE] reviewKeep abreast of current Industry trends, knowledge, developments and advances in area e.g. attending and contributing to regulatory code compliance workstreamsManage daily assignments, planning and directing work, and take responsibility for managing workload for assigned projects and tasks, in collaboration with senior staff”Contribute to budget proposals for compliance activities and maintain a clear understanding of the time and resources needed for tasks within remitAudit LeadProactive conduct regular audits to identify and document findings clearly, in accordance with defined proceduresIdentify root causes, CAPA development, management and implementation and reviewDevelop internal controls and monitor adherenceAdvising / supervising external client audits if requiredLiaise with customer where requiredSuccessful candidates will have:
Essential skills3-5 years relevant experience in pharmaceutical review (AQP / Sig) and / or complianceStrong ABPI / EFPIA / IPHA and PhRMA code knowledgeLife Science degree or higherExcellent written and oral communication skillsDemonstrates ability to remain calm and assertive, yet diplomatic in challenging interactions with customers and colleaguesDemonstrates initiative and sound judgement when faced with less familiar project/document situations or challengesSelf-starter – ability to work under own direction with confidenceAbility to establish and maintain effective working relationships with co-workers, managers and customers at a senior levelAbility to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with colleagues and customersConfidence in appropriately challenging the customer when document quality or timelines are at riskExperienced in coaching, mentoring or managing othersExperience working in a fast-paced environmentExperience in building strong collaborative partnershipsExperience problem solving and providing solutionsExperience working in Veeva Vault PromoMats/MedComms, Aprimo, Vodori, Ziflow or similar SaaS review and approval systemDesirable skills or qualifications:Masters or PhD in life sciences or industry related experience3Signatory/AQP expertiseMedical of Pharmacist qualificationIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

Expected salary

Location

London

Job date

Thu, 27 Mar 2025 05:44:12 GMT

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