Home Based, US

The Quality Assurance (QA) Senior Auditor 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 Sr Auditor to plan and conduct internal and external audits independently and to be able to mentor less experienced auditors. In liaison with Quality Assurance (QA) Management and staff, provide direction and coordination for project activities related to assigned areas. The Sr Auditor will also provide advice on regulatory compliance.

Key Accountabilities:
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.

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.

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 Client Audits and Regulatory Inspections

• Facilitate client audits / regulatory inspections, as assigned.

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.

Qualifications

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.

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.

EEO Disclaimer

Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.