Quality Client Representative

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. This position reports to the Quality Manager.

• Primary quality contact for assigned clients 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 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 as the Quality representative in a timely manner.
• Partner 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 interaction with client; 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 that govern 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 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.).

• 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.

• Day One Benefits
  • 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.

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