Senior Technology Auditor, QA

When our values align, there's no limit to what we can achieve. At Parexel , we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel , contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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

Work well in a team environment.

Liaise with clients and operational staff on quality aspects which may include attendance of meetings, presentations and audits

Perform other quality related task or initiatives as assigned Skills:

Ability to rapidly learn, understand and apply applicable Parexel and client procedures

Ability to work flexible and across multicultural environment

Ability to learn and use Parexel and client computer systems

Client focused approach to work

Ability to develop good working relationships with a culturally diverse group of Parexel and client personnel

Willingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamwork