Quality Management System Oversight Lead

Job details

Key Accountabilities:

Quality Management System (QMS)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

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
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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