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.