Parexel

Quality Management System Oversight Lead

China · Work style not stated · Full time

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About the role

Description from the employer’s posting. Check the employer’s page for the current version.

  • EmployerParexel
  • LocationChina
  • Work styleWork style not stated
  • Employment typeFull time
  • Employer posted

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.

Key Accountabilities:

QMSO Support processes

  • Support the execution of Parexel Quality's strategy and Parexel's QMS
  • As assigned, support execution of the strategic and tactical goals of QMSO for the key QMS elements, including, but not limited to: QMS infrastructure, Quality Issue Management, Management Review, Change Management, Process Optimization, Controlled Documents, Knowledge Management, and Risk Management.
  • Work to continuously improve Parexel’s QMS.
  • Maintain a familiarity with Parexel QMS-related systems and related
  • Provide coaching, mentoring and constructive feedback to QMSO staff as required.
  • Manage projects and initiatives as assigned, including participants, reporting and escalations as needed. Ensure that project / initiative resources are adequate. If they are not, escalate and either obtain the necessary resources or reprioritize work according to available resources.
  • Support management of the QMSO budget.
Show full description

Parexel Quality Department Support

  • Support Corporate Quality in the attendance, preparation for and follow up of internal/external audits and inspections as required.
  • Work with Corporate Quality to develop and/or update quality/process documents, tools, and templates. Consider process for effectiveness measurement.
  • Provide technical knowledge and oversight (including Quality eQMS applications business leadership) and serve as an escalation point where appropriate.
  • Maintain a positive, results oriented work environment, building partnerships within the group and across the organization at large, modeling teamwork
  • Remain informed about developments in relevant regulations and guidelines.
  • Support Operations staff in the use of automated quality systems; summarize automated quality system reports and provide metrics as appropriate.
  • Work with the relevant training functions including Learning & Development. Assist with the development or enhancement of training materials as assigned.

Global Organization Support

  • Present QMS to clients, auditors and regulatory inspectors
  • Lead cross functional improvements projects as required

Skills:

  • Excellent interpersonal, verbal and written communication skills
  • Customer focused approach to work
  • A flexible attitude with respect to work assignments and new learning
  • Ability to manage and prioritize tasks efficiently and accurately
  • Willingness to work in a matrix environment and to value the importance of teamwork
  • Understanding of audit/inspection process
  • Ability to lead projects and teams
  • Strong ability to analyze and interpret data
  • Attention to detail and advanced organizational skills
  • 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
  • Culturally aware and ability to think and work globally
  • English proficiency (written and oral English)

Knowledge and Experience:

  • 5 to 8 years work experience
  • Substantial experience in Clinical Research field (pharmaceutical industry or CRO) or other pertinent experience in the areas of QMS support required
  • Knowledge of GxP compliance as required
  • Relevant experience in Quality Management
  • Clinical Lead, Clinical Operations Lead, Lead CRAs (or equivalent roles) with extensive experience in Quality Events (Quality Issues or Audits/ Inspections Findings) would be considered relevant.
  • Technology / Business Operations experience, as appropriate, preferred
  • Leadership and/or project management experience preferred
  • Training experience required
  • Substantial experience working in a global environment

Education:

  • Bachelor’s Degree or other relevant experience required. Life-science or other health-related discipline preferred.
  • Master’s Degree in a science, technology or industry-related disciple preferred.

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At a glance

  • Employment typeFull time
  • SeniorityLead / Principal
  • Employer posted
  • Added to ROLIVA
  • Last checked

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