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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Management Systems (QMS) and GxP compliance, with a strong background in clinical research and project management. Capable of leading cross-functional improvement projects and providing training and mentorship to staff in a global environment.
Highest-signal resume keywords
Quality Management Systems (QMS)GxP ComplianceProject ManagementClinical Research ExperienceTraining Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Management TechnologyBudget ManagementProcess ImprovementAudit PreparationTechnical Oversight
Soft Skills
CoachingMentoringConstructive FeedbackResults OrientedCollaboration
Tools & Technologies
QMS-Related SystemsQuality/Process DocumentsTemplates
Industry Keywords
Pharmaceutical IndustryCROLife-ScienceHealth-Related Discipline
About the role
Key responsibilities & impact- Support the execution of Parexel Quality's strategy and Parexel's QMS.
- Support execution of the strategic and tactical goals of QMSO for the key QMS elements.
- Work to continuously improve Parexel’s QMS.
- Maintain a familiarity with Parexel QMS-related systems.
- Provide coaching, mentoring and constructive feedback to QMSO staff as required.
- Manage projects and initiatives as assigned, including participants, reporting and escalations as needed.
- Support management of the QMSO budget.
- Support Corporate Quality in the attendance, preparation for and follow up of internal/external audits and inspections.
- Work with Corporate Quality to develop and/or update quality/process documents, tools, and templates.
- Provide technical knowledge and oversight and serve as an escalation point where appropriate.
- Maintain a positive, results oriented work environment.
- Present QMS to clients, auditors and regulatory inspectors.
- Lead cross functional improvements projects as required.
Requirements
What you’ll need- 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 Technology / Business Operations experience, as appropriate, preferred
- Leadership and/or project management experience preferred
- Training experience required
- Substantial experience working in a global environment.
- 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.
Benefits
Comp & perks- Health insurance
- Professional development opportunities
- Paid time off
