Quality Management System Oversight Lead

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds 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 were committed to making a difference.

Key Accountabilities:

QMSO Support processes

• Support the execution of Parexel Qualitys strategy and Parexels 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 Parexels 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:

• Bachelors Degree or other relevant experience required. Life-science or other health-related discipline preferred.
• Masters Degree in a science technology or industry-related disciple preferred.