- 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.
- Ability to rapidly learn, understand and apply applicable Parexel and client procedures.
- 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.
- 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.
- Lead and coordinate internal regional and 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.
- 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.
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Senior Quality Assurance Auditor - Billerica, United States - PAREXEL
Description
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:
What you'll do:
Additional Details:
Ability to travel internationally for audits as required. Travel time could be up to approx. 60%.
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
Full list of benefits available here:
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 we embrace flexibility and understand that in today's fast-paced world, employees need to balance their careers with their personal lives. Come join us where learning is constant, and you're exposed to a world of experiences and open doors.
#LI-REMOTE
