Quality Client Representative

About the role

The Quality Client Representative is a member of the core client team and interacts directly with clients. The Quality Client Representative is responsible for all quality aspects of the project and provides exemplary customer service to both internal and external customers by focusing on quality and compliance.

Responsibilities

• Primary quality contact for assigned clients externally and internally.
• Manages client project quality updates and reviews with all levels of management.
• Responsible for making and delivering accurate and timely quality decisions pertaining to client projects, questions, and quality requests.
• Escalates quality issues to impacted departmental quality manager and/or Quality Director as necessary for corrective action implementation.
• PARTNERS WITH MANAGER AND QUALITY LEADERSHIP STAFF TO AUTHOR, DRIVE OR APPROVE APPLICABLE QUALITY DOCUMENTS, AS THE QUALITY REPRESENTATIVE IN A TIMELY MANNER.
• PARTNERS WITH PROGRAM MANAGER, TECHNICAL SERVICES REPRESENTATIVES, QUALITY CONTROL REPRESENTATIVE AND MANUFACTURING REPRESENTATIVE TO COORDINATE PROJECTS, PROVIDE SUPPORT, ALIGN FACILITY REPRESENTATION, AND PROVIDE CONSISTENT QUALITY INFORMATION.
• REPRESENTS QUALITY IN REQUIRED PROJECT CLIENT MEETINGS.
• Understands the quality and technical requirements of each project.
• Maintains Project File, including recording and tracking quality interaction with client.
• TRACKS, TREND, COMPILE, AND REPORT CLIENT QUALITY METRICS AS NECESSARY.
• THOROUGHLY UNDERSTANDS THE QUALITY AGREEMENT, MASTER BATCH RECORD (MBR), QUALITY CONTROL MASTER DOCUMENT (QCMD), REGULATORY AND PROCEDURAL REQUIREMENTS THAT GOVERN THE CLIENT/COMPANY RELATIONSHIP AND PRODUCT.
• AID AND LEAD QUALITY AGREEMENT CONTRACT NEGOTIATIONS.
• IDENTIFIES AND LEADS CONTINUOUS IMPROVEMENT ACTIVITIES TO MAXIMIZE BUSINESS RESULTS.

Requirements

• Bachelor’s degree required, preferably in a science related field with 5 years pharmaceutical industry experience or a Master's degree with 3 years of pharmaceutical experience.
• Familiar with quality operating procedures, quality, and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality.
• Knowledge of worldwide regulatory requirements.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, Blue Mountain, Trackwise, etc.).

Physical / Safety Requirements

• Duties may require overtime work, including nights and weekends.
• Use of hands and fingers to manipulate office equipment is required.
• Position may require sitting or standing for long hours of time.