Join Parexel’s team of changemakers as we help advance healthcare throughout the globe, all while keeping the patient at the heart of everything we do.
At Parexel, we are a leading Clinical Research Organization (CRO) company specializing in delivering life
- changing medicines to patients. We are seeking a Senior Quality Assurance Auditor to join our team. Our Senior Quality Assurance Auditor works toward building a deeper connection and understanding with those who count on us most. Through questioning the status quo and collaborating cross-functionally, the Senior Quality Assurance Auditor is responsible for leading, planning, scheduling, performing, and reporting a range of GxP audits across all phases of Clinical Research.
**Title**:Senior Quality Assurance Auditor (GCP Auditor)
**Who we’re looking for**:
- Minimum of 2 years’ experience in quality assurance, auditing, including sound experience of applicable GxP auditing.
- At least 5 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.
- Ability to travel internationally for audits as required. Travel time could be up to approx. 60%.
- 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.
- Client focused approach to work.
- 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.
- 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.
- 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.
**What you’ll do**:
- Lead, Perform and Report audits for area of specialization, work with internal customers and develop and execute strategic audit plans for the area.
- Manage GxP audits.
- Report outcome and trends of audit program to the process owner, QA Senior Management.
- Review audit reports, responses, and other program deliverable to ensure consistent high quality.
- 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.
- 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 of new / less experienced auditors by performing co-audits, assist in developing training materials/tools, delivering training, and sharing knowledge and experience.
- Maintain QA records / systems.
- Process improvements: Optimize new and existing processes to maintain and improve quality standards including supporting quality initiatives as assigned.
- Provide local, regional, and global consultancy 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 Sponsor Audits and Regulatory Inspections, as assigned.
- Liaise with external industry and regulatory inspectorate contacts and networks to determine best practice regarding implementation of relevant GxP requirements across the Parexel Corporation.
- Maintain sound knowledge of Parexel policies, procedures, and guidelines and promote compliance within Parexel.
- Maintain compliance with training curriculum.
- Build, develop, and maintain good working relationships with internal and external customer groups.
- Work well in a team environment.
- Perform other quality related tasks or initiatives as assigned.
**Additional Details**:
Ability to travel nationally and internationally for audits as required.
**Why join us**:
Be part of groundbreaking projects that are pushing the boundaries of the industry.
Experience a collaborative and inclusive work environment that highly appreciates your expertise. Unlock your full potential with professional growth and development opportunities.
Enjoy work life balance and flexible working hours.
**Parexel US Benefits**:
Health, Vision & Dental Insurance
Tuition Reimbursement
Vacation/Holiday/Sick Time
Flexible Spending & Health Savings Accounts
Work/Life Balance
401(k) with Company match
Pet Insurance
If this job doesn’t sound like the next step in your career, but perhaps you know of someone who’d be a perfect fit, send them the link to apply!
At Parexel w