Quality Client Representative

Overview

Simtra Bio Pharma 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, USA 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 focus on quality and continuous improvement extends to biologics, small molecules, cytotoxics, highly potent compounds, diluents and vaccines—all directly injected into patients worldwide.

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

• Primary quality contact for assigned clients, both externally and internally.
• Manage client project quality updates and reviews with all levels of management.
• Make and deliver accurate and timely quality decisions pertaining to client projects, questions, and quality requests.
• Escalate quality issues to the impacted departmental quality manager and/or Quality Director as necessary for corrective action implementation.
• Partner with manager and quality leadership staff to author, drive or approve applicable quality documents in a timely manner.
• Collaborate 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.
• Represent quality in required Project Client Meetings.
• Understand the quality and technical requirements of each project.
• Maintain Project File, including recording and tracking quality interactions with client, and track, trend, compile, and report client quality metrics as necessary.
• Thoroughly understand the Quality Agreement, Master Batch Record (M ), Quality Control Master Document (QCMD), regulatory and procedural requirements governing the client/company relationship and product.
• Assist and lead quality agreement contract negotiations.
• Identify and lead continuous improvement activities to maximize business results.

• Bachelor’s degree required, preferably in a science‑related field with 5 years of pharmaceutical industry experience, or a Master’s degree with 3 years of pharmaceutical experience.
• Familiar with quality operating procedures, quality regulation, and requirements pertinent to pharmaceutical, biological and biochemical quality.
• Knowledge of worldwide regulatory requirements.
• Computer proficiency in Microsoft Word, Excel, Outlook, and the ability to use enterprise software.

• 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 periods of time.

• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
  • Spouse Life Insurance
  • Child Life Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
  • Paid Holidays
  • Paid Time Off
  • Paid Parental Leave and more
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
• Voluntary Insurance Benefits
  • Vision Coverage
  • Accident
  • Critical Illness
  • Hospital Indemnity Insurance
  • Identity Theft Protection
  • Legal and more
• Onsite Campus Amenities
  • Workout Facility
  • Cafeteria
  • Credit Union

[1] Current benefit offerings are in effect through 12/31/26.

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.