Quality Management System Oversight Lead

Key Accountabilities

• 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, elevate and either obtain the necessary resources or reprioritize work according to available resources.

• Support management of the QMSO budget.

• 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.

• Present QMS to clients, auditors and regulatory inspectors

• Lead cross functional improvements projects as required

• 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)

• 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.

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.