Accountability/Supporting Activities

Perform and Report audits

• Independently plan, schedule, perform and report a range of GxP audits across all phases of Clinical Research including, but not limited to project related audits, system audits, supplier audits, safety/pharmacovigilance (PV) audits.
• Perform and deliver high quality audits /audit reports within specified timelines / budgets, with limited oversight. Lead or participate in co-audits / observed audits with client representatives or other QA auditors.
• Travel internationally for audits as required. Travel time could be up to approx. 60%

Follow-up audits

• Collect and review responses to audit observations and follow-up / escalate inadequate or delayed responses as necessary to ensure timelines are met and responses of satisfactory quality are obtained.

Lead internal and billable audit programs

• Work with client QA and Parexel Operations to plan and manage a global program of audits.
• 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 deliverable to ensure consistent high quality.

Billable Audits/Audit programs & Client Relationships (where applicable)

• Act as QA Lead on audits program(s) as assigned by Line Management.
• Ensure audits programs are managed to a high degree of client satisfaction.
• Arrange meetings with client and other key stakeholders as required.
• 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.
• 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 auditor training

• Assist with the training of new / less experienced auditors by performing co-audits, delivering training, and sharing knowledge and experience.

Maintain records / systems

• Maintain required QA tools and ensure Parexel and QA systems are regularly updated with accurate information for audits and other activities.

Understand Parexel policies, procedures, and guidelines

• Maintain compliance with training curriculum.
• Review Parexel SOPs as assigned to ensure GxP compliance of processes.

Process improvements

• Support QA Management to analyze audit activities and provide metrics to relevant parties (QA, Operations, Procurement).

Provide local, regional and global consultancy

• Provide advice 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 and strategy as requested.

Support Client Audits and Regulatory Inspections

• Facilitate client audits / regulatory inspections, as assigned.
• Foster a good working relationship with internal and external clients.

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.

Build and maintain relationships

• Build, and maintain good working relationships with internal and external customer groups
• Work well in team environment.

Perform other quality related task or projects as assigned

• Perform other quality related tasks or initiatives as assigned.

Skills:

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

Knowledge and Experience:

• Preferred minimum of 2 years’ experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area such as technology, third party supplier management, including sound experience of applicable GxP auditing
• Preferred minimum of two year experience
• 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
• Experience with using computer systems and software, including Microsoft Office
• Auditors must be detail oriented, 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.

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.