Quality Client Representative

Simtra BioPharma Solutions•Bloomington, IN

1d•Onsite

About The Position

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization (CDMO) that partners with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, Simtra offers a wide range of delivery systems and product types, including biologics, small molecules, cytotoxics, highly potent compounds, diluents, and vaccines, all directly injected into patients worldwide. The company emphasizes quality and continuous improvement, adhering to the highest quality and regulatory standards. Beyond cGMP manufacturing, Simtra provides support services such as formulation and development, lyophilization optimization, global regulatory support, and secondary packaging. The teams are dedicated to helping clients scale, innovate, and deliver life-changing medicines to patients globally. The Quality Client Representative is a core member of the client team, interacting directly with clients and responsible for all quality aspects of projects. This role provides exemplary customer service, focusing on quality and compliance, and reports to the Quality Manager.

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: JDE, BPLM, Pilgrim, Trackwise, etc.).

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.
Assist and lead quality agreement contract negotiations.
Identifies and leads continuous improvement activities to maximize business results.