Quality Client Representative

Simtra BioPharma Solutions•Bloomington, IN

About The Position

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. Why join Team Simtra? Because we: Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers. Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways. Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members. Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health. 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. This position reports to the Quality Manager.

Requirements

Bachelor’s degree required (preferably in a science related field) with 5 years of pharmaceutical 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.)
Duties may require overtime work, including nights and weekends
Requires manual dexterity to operate office equipment
Position may require sitting or standing for long hours of time

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.