Sr. Quality Assurance Auditor GCP GXP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

• 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.
  • 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.

  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.
  • 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