Quality Lead II

Support the continuous improvement of key components of the Quality Management System (QMS) and related standards. Work with QMSO leadership to assess and report on the functioning of components constituting the QMS.

Supporting Activities

QMSO Support

• As assigned, complete QMSO goals for the key QMS elements.
• Maintain a familiarity with Parexel QMS-related applications and related processes.
• Participate in projects and initiatives as assigned, including reporting information and escalations as needed.
• Remain informed about developments in relevant regulations and guidelines.
• Provide technical knowledge where appropriate.

• Support Operations staff in the use of electronic quality systems; summarize automated quality system reports and provide metrics as appropriate.
• Support the review of QMS processes.
• Assist in the maintenance of the relevant website, Parexel Connect page and filing areas, as needed.

Parexel Quality Department Support

• Support Corporate Quality in the 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.
• Maintain a positive, results oriented work environment
• Communicate in an open, balanced and objective manner.

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:

• 2 to 5 years work experience
• Extensive experience in a Clinical Research field (pharmaceutical industry or CRO) or other relevant experience in the areas of QMS support required
• Knowledge of Good Practices (GxP) compliance required
• Project Management / Technology / Business Operations experience, as appropriate, preferred

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.