About this role
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.
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.