Quality Management System Oversight Lead

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.