Quality Integration Project Manager

At Proclinical we are seeking a talented and experienced individual to fill the role of Quality Integration Project Manager, based in Irvine, CA.

Responsibilities

• Prepare analytics and presentations.
• Publish meeting minutes and follow up.
• Track completion of tasks and facilitate resolution of issues.
• Escalate issues to management as needed.
• Review documentation and provide feedback.
• Facilitate document reviews and approvals.
• Interact with document and records management teams/systems to ensure all appropriate documentation that requires obsolescence/revision are identified for each integration element.
• Provide strategies for change management tasks to ensure accuracy/efficiency.
• Assist with identification of training requirements and training implementation.
• Perform assigned Quality System procedure gap assessments.

Skills And Qualifications

• BA in related field with 4+ years of clinical or related technical experience required.
• Excellent written, verbal and interpersonal communication skills.
• Strong knowledge of Microsoft Office Suite.
• Knowledge of regulations pertaining to medical devices.
• Experience in FDA/EU regulated business environment, project management, change management, Quality Systems, auditing, document management.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Mary Jacobs at (+1) 2674774800 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.