The Compliance Lead is a senior member of the Qualityand Compliance Team responsible for monitoring and maintaininginternal compliance in line with External regulations andrequirements and internal policies, in order to meet qualityexpectations. An escalation point for compliance and Code queriesand acts as an Any Qualified Person (AQP, non-medical signatory) ormedical signatory. Responsibilities: The Compliance Lead atPharmaReview is responsible for: - Being a subject matter expertwithin the group and a source of advice and information to IQVIAstaff on quality control processes - Identifying quality andcompliance issues, providing solutions and preventative actions -Demonstrating commitment to exploring optimal ways of working -Setting standards for the team - Development, maintenance, andtraining of Policies, SOPs, Work Instructions. Liaise promptly withprocess owners / document authors in case of questions - Developquality tools such as checklists and quality guidelines. -Smartsolve Quality Management System administrator - GCP TrainingRecords management in collaboration with Training manager - Primarycontact for IQVIA Quality and Compliance Team - Coordinatingcompliance training with the medical director / training managerincluding Code Clinic agendas, ‘HOT TOPICs’ and other areas ofidentified need - Take a leading role in providing training,guidance, and mentoring, including standardised measurements toensure consistency across teams and best practice is adopted - Leadrole in proposing, developing, evaluating, and implementing processchanges and tools and monitoring their adoption and benefits -Understanding external client’s compliance needs and ensuringinternal policies and activities meet this and vice versa;collaborate with AL for onboarding and EBR on compliance aspects -Act as escalation point for Third Pair of Eyes [TPOE] review - Keepabreast of current Industry trends, knowledge, developments andadvances in area e.g. attending and contributing to regulatory codecompliance workstreams - Manage daily assignments, planning anddirecting work, and take responsibility for managing workload forassigned projects and tasks, in collaboration with senior staff -Contribute to budget proposals for compliance activities andmaintain a clear understanding of the time and resources needed fortasks within remit Audit Lead - Proactive conduct regular audits toidentify and document findings clearly, in accordance with definedprocedures - Identify root causes, CAPA development, management andimplementation and review - Develop internal controls and monitoradherence - Advising / supervising external client audits ifrequired - Liaise with customer where required Successfulcandidates will have: Essential skills - 3-5 years relevantexperience in pharmaceutical review (AQP / Sig) and / or compliance- Strong ABPI / EFPIA / IPHA and PhRMA code knowledge - LifeScience degree or higher - Excellent written and oral communicationskills - Demonstrates ability to remain calm and assertive, yetdiplomatic in challenging interactions with customers andcolleagues - Demonstrates initiative and sound judgement when facedwith less familiar project/document situations or challenges -Self-starter – ability to work under own direction with confidence- Ability to establish and maintain effective working relationshipswith co-workers, managers and customers at a senior level - Abilityto proactively evaluate risks and potential issues and seeksolutions and discuss appropriately with colleagues and customers -Confidence in appropriately challenging the customer when documentquality or timelines are at risk - Experienced in coaching,mentoring or managing others - Experience working in a fast-pacedenvironment - Experience in building strong collaborativepartnerships - Experience problem solving and providing solutions -Experience working in Veeva Vault PromoMats/MedComms, Aprimo,Vodori, Ziflow or similar SaaS review and approval system Desirableskills or qualifications: - Masters or PhD in life sciences orindustry related experience - Signatory/AQP expertise - Medical orPharmacist qualification IQVIA is a leading global provider ofclinical research services, commercial insights and healthcareintelligence to the life sciences and healthcare industries. Wecreate intelligent connections to accelerate the development andcommercialization of innovative medical treatments to help improvepatient outcomes and population health worldwide. Learn more athttps://jobs.iqvia.com #J-18808-Ljbffr
