Senior Technology Auditor, QA

Job description

**Key Accountabilities**: **Lead, Perform and Report audits** - Independently 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 audits** - Collect 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 functions - Resolve 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 Breaches** - Support 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 Mentoring** - Support 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 guidance **Maintain QA records / systems** - Provide QA Senior Management with informational reports upon request on assigned areas - Maintain 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 areas **Process improvements** - Optimize new and existing processes to maintain and improve quality standards including supporting quality initiatives as assigned - Support 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 consultancy** - Provide 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 Inspections** - Facilitate 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 Corporation **Maintain sound knowledge of Parexel policies, procedures, and guidelines and promote compliance within Parexel** - Working 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 standards - Review Parexel SOPs as assigned to ensure GxP compliance of processes - Maintain compliance with training curriculum. **Build and maintain relationships** - Build, develop, and maintain good working relationships with internal and external customer groups - Wor