Quality Manager Representative - Colorado Springs-South, CO

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Job Description

About BioLife Plasma Services

Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.

BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.

This exciting and unique opportunity to be part of a new team as we expand our network provides great opportunities to grow a career while also directly impacting our ability to support more patient needs.  Upon applying, please note your email address on your profile and check that regularly as we will send updates throughout the application process

Position will be based out of our brand new plasma donation facility in the  opening November 2025!

OBJECTIVES/PURPOSE

Monitors all systems and activities to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations for a plasma center. Authorized and responsible to cease operations within the center or stop source plasma shipment(s) if product or donor safety is or may be compromised.

All below listed responsibilities must be completed in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety, and to the proper performance of day-to-day activities. Employees must also maintain complete and accurate records, in accordance with cGMP.

ACCOUNTABILITIES

• Regulatory Compliance: (15%)
  • Stays current with federal, state, local and company-specific rules, regulations, and practices.
  • Ensures center compliance with all federal, state, local and company-specific regulations related to quality of product, employee and donor safety.
  • Ensures that SOP’s are current and that staff perform routine tasks according to SOP through direct observation.
• Plasma Collection Center Quality Assurance Oversight: (80%)
  • Reviews operational records to ensure they are complete, accurate and compliant with cGMP requirements.
  • Tracks deviations and trending in operating procedures and policies through established mechanisms. Reports errors, deficiencies, discrepancies and observations to center management and the Regional Quality Manager. May stop operations or shipments when donor or product safety is or may be compromised.
  • Identifies potential SOP revisions as needed to support continuous improvement.
  • Works in collaboration with center manager and management team to prepare for and host (if needed) internal auditors and external inspectors. Assists center management teams to ensure timely closure of audit observations.
  • Tracks responses to and evaluates effectiveness of corrective actions for errors.
  • Conducts monthly quality assurance audits for critical control points and key elements for the systems related to donor suitability, source plasma collection, sample collection, plasma storage, product release, quality assurance, and employee training program.
  • Coordinates management review meetings and participates in center staff meetings.
• Employee Recruitment and Retention: (5%)
  • Responsible for providing feedback and developing employees in the quality department. Provides feedback during the recruitment process for quality department employees, including performance evaluations and merit