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Responsibilities
Key Accountabilities:Lead, Perform and Report auditsIndependently lead, plan, schedule, perform, and report a range of GxP audits across all phases of Clinical Research which may include but are not limited to project related audits, system and process audits, supplier qualification and re-qualification audits (including GMP & GLP as well as GCLP accreditation audits), Trial Master File audit, safety/pharmacovigilance (PV) audits in order to evaluate the quality system against the appropriate regulatory requirements, relevant procedures and applicable guidelines.Perform and deliver high quality audits/audit reports within specified timelines / budgets, independently or with limited oversight. Lead or participate in complex audits including for-cause audits/ co-audits / observed audits with client representatives or other QA auditors.Ability to review and, if necessary, identify improvements that enhance the quality and clarity of audit reports.For area of specialization, work with internal customers and develop and execute strategic audit plans for the area.Travel internationally for audits as required. Travel time could be up to approx. 60%.Manage GxP auditsCollect and review responses to audit findings and follow-up ! escalate inadequate or delayed responses as necessary to ensure timelines are met and responses of satisfactory quality are obtained and formally recorded.Act as point of consultancy for Operations and Quality with regards to the implementation of adequate CAPAs with effective and timely escalation of relevant Quality Events where required.Lead and coordinate internal audit programs (global and regional)Coordinate internal global process/system audits across regions and develop all necessary tools such as report templates, checklists and standard emails.Report outcome and trends of audit program to the process owner, QA Senior Management.Escalate quality and compliance issue trends to QA Senior Management and relevant operational functionsResolve program related issues in a constructive and pro-active way.Ensure required audits are performed and reported in accordance with Parexel QA requirements, and on time.Review audit reports, responses and other program deliverables to ensure consistent high quality.Billable Audits/Audit programs & Client Relationships (where applicable)Act as QA Lead on audits program(s)Arrange meetings with client and other key stakeholders as required to plan a program of contracted audits.Ensure required audits are delivered in accordance with clients’ requirements and Parexel client procedures as applicable.Ensure that systematic issues raised during billable audits are escalated and addressed.Maintain relationships with clients and ensure audits programs are managed to a high degree of client satisfaction.Support client QA needs and identify areas where billable services may be offered.Develop and optimize new and existing processes to maintain and improve quality within the billable group.Support Serious BreachesSupport Serious Breaches (SB) investigations and help oversee the project teams to reach final conclusion regarding the reportability of a critical Quality Event.Support auditor training and MentoringSupport the training and mentoring of new / less experienced auditors by performing co-audits, delivering training, and sharing knowledge and experience.Assist in developing training materials, auditing tools, templates and guidanceMaintain QA records / systemsProvide QA Senior Management with informational reports upon request on assigned areasMaintain required QA tools and ensure Parexel and QA systems are regularly updated with accurate information for audits and other activities.Maintain current records / documents related to assigned areasProcess improvementsOptimize new and existing processes to maintain and improve quality standards including supporting quality initiatives as assignedSupport QA Management in development of audit plan, to analyze audit activities and provide metrics to relevant parties (QA, Operations, Procurement).Proactively recognize areas for process / procedural improvements, providing input to QA management and taking the initiative, as appropriate.Provide local, regional and global consultancyProvide consultation and interpretation on regulatory compliance to internal/external clients, Parexel management, and staff with regards to the implementation of GxP and safety/PV requirements, and implementation of appropriate regulatory requirements.Support the development, maintenance, review and improvement of Parexel procedures, systems and tools by providing constructive ideas and suggestions.Provide input on QA planning including audit planning and strategy as requested.Support Sponsor Audits and Regulatory InspectionsFacilitate client audits / regulatory inspections, as assigned.Liaise with external industry and regulatory inspectorate contacts and networks to determine best practice with regard to implementation of relevant GxP requirements across the Parexel CorporationMaintain sound knowledge of Parexel policies, procedures, and guidelines and promote compliance within ParexelWorking knowledge and expertise of Parexel policies, procedures, and guidelines, as well as applicable national and international regulations and requirements; able to apply them as needed.Proactively recognize areas for process / procedural improvements, providing input to management and taking the initiative, as appropriate.Recognize, exemplify and adhere to Parexel values and standardsReview Parexel SOPs as assigned to ensure GxP compliance of processesMaintain compliance with training curriculum.Build and maintain relationshipsBuild, develop, and maintain good working relationships with internal and external customer groupsWork well in a team environment.Liaise with clients and operational staff on quality aspects which may include attendance of meetings, presentations and auditsPerform other quality related task or initiatives as assignedSkills: Ability to rapidly learn, understand and apply applicable Parexel and client proceduresAbility to work flexible and across multicultural environmentAbility to learn and use Parexel and client computer systemsClient focused approach to workAbility to develop good working relationships with a culturally diverse group of Parexel and client personnelWillingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamworkExcellent interpersonal, verbal, and written communication skills, including the ability to present at conferences, meetings and training sessionsAbility to mentor / train auditors and other personnelExcellent organizational, analytical, problem solving, decision making and negotiation skillsEffective at analyzing problems considering the ‘big picture’ and recommending appropriate corrective actionsAbility to work independently and consistently in a fast-paced environment.Accurate and detail oriented, a critical thinkerExcellent time management skills with the ability to prioritize workload and manage multiple and varied tasks / projects with enthusiasmA flexible attitude to work assignments and new learning and the ability to adjust to changing priorities and unforeseen eventsAbility to diplomatically address sensitive issues confidentially and professionallyAbility to work professionally with highly confidential informationTeam leadership abilities and positive attitude. Experience with using computer systems and software, including Microsoft OfficeAuditors must be detail oriented, good at decision making, able to maintain a ‘big picture’ / overview on the project / businessAbility to follow up on multiple tasks and projects, and to handle confidential information diplomatically.Knowledge and Experience:Minimum of 4 years experience in quality assurance, auditing, including sound experience of applicable GxP auditingAt least 7 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area in life science such as technology, third party supplier managementExcellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical researchEducation: Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experienceMaster’s degree in a science, technology or industry related discipline, preferred.Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere.Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.
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