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Job Description
Simtra BioPharma Solutions is seeking a Manager I, Quality Client Services to act as a liaison between Simtra and its clients regarding quality-related activities. This role involves managing Quality Client Representatives who serve as primary Quality contacts with clients. The position reports to the Sr Manager of Quality Assurance Product Release and Quality Client Representation.

Responsibilities:
  • Manage Quality Client Representatives.
  • Manage client project quality updates and reviews with all levels of management.
  • Making 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.
  • May oversee quality system, such as CAPA or NCR.
  • Partners with Quality leadership to sign off on applicable documentation that may include: validations, protocols, non-conformances, CAPA, and annual product reviews.
  • Review and approve exception reports as needed to meet client delivery dates and expectations.
  • Represent Quality in required Project Client Meetings.
  • Track, trend, compile and report client quality metrics as necessary.
  • Negotiate and provide guidance in the approval process of Quality Agreements.
  • Lead continuous improvement activities to maximize business results.

Requirements:
  • Bachelor’s Degree required, preferred science-related field.
  • Minimum 5 years experience in pharmaceutical and 1-2 years of supervisory experience.
  • Knowledge of quality operating procedures and quality and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality.
  • Project management and customer service experience required.
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Simtra BioPharma Solutions offers:
  • Day One Benefits (Medical & Dental Coverage, Flexible Spending Accounts, Life and AD&D Insurance, etc.)
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program (Paid Holidays, Paid Time Off, Paid Parental Leave)
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
  • Onsite Campus Amenities (Workout Facility, Cafeteria, Credit Union)
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