Quality Client Representative

About the role

The Quality Client Representative plays a crucial role in ensuring quality and compliance for assigned clients. They interact directly with clients, manage quality updates, and make timely decisions regarding project quality.

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.
• Track, 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.
• Identify and lead 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.