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
• Excellent interpersonal, verbal, and written communication skills, including the ability to present at conferences, meetings and training sessions
• Ability to mentor / train auditors and other personnel
• Excellent organizational, analytical, problem solving, decision making and negotiation skills
• Effective at analyzing problems considering the ‘big picture’ and recommending appropriate corrective actions
• Ability to work independently and consistently in a fast-paced environment.
• Accurate and detail oriented, a critical thinker
• Excellent time management skills with the ability to prioritize workload and manage multiple and varied tasks / projects with enthusiasm
• A flexible attitude to work assignments and new learning and the ability to adjust to changing priorities and unforeseen events
• Ability to diplomatically address sensitive issues confidentially and professionally
• Ability to work professionally with highly confidential information
• Team leadership abilities and positive attitude. Experience with using computer systems and software, including Microsoft Office
• Auditors must be detail oriented, good at decision making, able to maintain a ‘big picture’ / overview on the project / business
• Ability 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 auditing
• At 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 management
• Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research

Education:

• Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
• Master’s degree in a science, technology or industry related discipline, preferred.