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Quality Assurance Opportunities at PAREXEL

By being hired into one of our Quality Assurance jobs at PAREXEL International, you’ll be a key member of the PAREXEL International team. Professionals in Quality careers come from a variety of backgrounds, bringing an assortment of knowledge and skills to every area of our business. A job in Quality at PAREXEL International may be waiting for you!

Quality Manager

Job ID 50354BR Shanghai, Shanghai Municipality, China
Provide quality support (development and implementation of quality framework) and quality consultancy to designated Operational groups
Provide GxP and process expertise to designated Operational group(s). Provide guidance for identification of process improvement opportunities, process authoring and review. Support the identification, management and prevention of quality issues and the analysis and reporting of quality metrics, as needed for the Management Review process. Provide process level audit and inspection support, as needed. Mentor and train Senior/Quality Specialists. Supervise quality management projects including the oversight of team members as assigned.
• Work with Operations, Operations QM and PQ to identify continuous improvement opportunities (based upon metrics quality and other objective information) and champion their implementation, as assigned.
• Use process mapping and analysis techniques to identify areas for efficiency gains and process improvements within Operations and Quality groups, subsequently developing and implementing action plans as appropriate.
• Work with the Process Optimization and Management (POM) and Operational groups; ensure timely review and maintenance of Controlled documents (e.g. SOPs, Work Instructions, Forms and Templates) in accordance with the defined timelines.
• Represent PM QM for SBU and Corporate process improvement initiatives as required.
• Maintain an excellent familiarity with PAREXEL project-related systems and related processes.
• Remain informed about developments in relevant regulations and guidelines.
• Where assigned, work with Operational groups to provide expert review of client-defined processes; provide process support and consultancy to partnerships as assigned
• As Process SME assist with the development or enhancement of training materials as assigned.
• Provide consultancy to Operations staff in the application of, and adherence to relevant processes.
• Support Quality and Operations staff in the coordination of, preparation for and follow up (incl. response review) of internal/external audits and inspections as required.
• Complete or oversee the completion of assigned quality interventions/targeted/independent quality assessments. Verify compliance with GxP guidelines, local regulations, protocol, PAREXEL procedures and/or sponsor requirements.
• Represent Quality Management in audits and inspections as required.
• Provide support for the management of relevant quality issues. Facilitate Root Cause Analysis and provide advice on corrections, corrective and preventive actions related to designated quality issues.
• Support Operations staff in the use of automated quality systems; summarize automated quality system reports and provide metrics as appropriate.
• Attend (or where required, lead) internal quality-focused meetings.
• Participate in development of quality-related processes and tools.
• Assist in the maintenance of relevant websites, PAREXEL Connect pages, and PMED filing areas as required.
• Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner.
• Support execution of the PAREXEL QMS
• Support Operations in the implementation of Management Review, Operational Risk Management and other elements of the QMS, as appropriate

Qualifications

Skills:
• Excellent interpersonal, verbal and written communication skills.
• Client focused approach to work.
• A flexible attitude with respect to work assignments and new learning.
• Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail and strong organizational skills
• Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization
• Ability to think and work globally and be culture aware
• Understanding of audit/inspection process.
• Strong ability to work independently and take ownership of, and responsibility for, work assigned.
• IT literate – Experience with Microsoft based applications and a general knowledge of PC functions.
• Ability to lead projects and teams cross functional
• Ability to lead a cross functional team to ensure delivery on time and to required standard for Quality and Company initiatives.
• English proficiency (written and oral English).
• Ability to travel as needed for the position.
Knowledge and Experience:
• Relevant experience in the Clinical Research field (pharmaceutical industry or CRO) or other relevant experience in the areas PM QM support, required
• Knowledge of GxP compliance required
• Relevant experience in Quality Management, preferred
• Leadership and/or project management experience, preferred
• Ability to analyze and interpret data
• Experience of working in a global environment
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

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