Senior Quality Assurance Auditor

The Senior Auditor Quality Assurance (QA) has an in-depth understanding and knowledge of appropriate GxP compliance and other applicable regulations and laws, Parexel procedures and appropriate Parexel processes, which allows the individual to plan and conduct internal and external audits independently and to be able to mentor less experienced auditors. In liaison with QA Management and staff, provide direction and coordination for project activities related to assigned areas. Provide advice on regulatory compliance.

What we expect from you:

• Fluent in English (oral and written) Mandatory
• Must have minimum 3 years of GCP auditing experience of clinical trials in CRO, biotech, and/ or pharmaceutical industries.
• GLP/ GCLP/ GMP prior auditing experience is a plus.
• Prior experience in conducting the following audit types is required:
  • GCP investigator site audits (all clinical trial phases)
  • TMF audits
  • Supplier audits
  • System audits
  • Process audits
  • PV audits
  • EP audits
• Experience hosting sponsor audits and regulatory inspections is a plus.
• Availability to travel 30-60% of time is required.
• Must have strong analytical, written & oral communication, interpersonal and organizational skills.
• Must have a thorough knowledge of the clinical trials conducted and applicable regulations.
• Educated to degree level (technology, biological science, pharmacy, or other health-related discipline preferred) or equivalent qualification or clinical research experience.

What you´ll do in the role

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%.
• 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.

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.