15 days old

Quality Lead, Collection Center - Based in Seattle

Be The Match
Seattle, WA 98104
  • Job Code
    190000GN

BE THE MATCH OPERATING PHILOSOPHY:

Right now, people's lives depend upon our performance. Our leaders have ownership of their areas, the autonomy to determine the best path, and the responsibility to ethically deliver excellent results. Both team members and leaders exemplify our Be The Match Standards.

POSITION SUMMARY:

This position will play a key role as Be The Match establishes its first Collection Center in Seattle, Washington. Our new collection center is being designed to deliver dedicated donor concierge services, implement an outstanding experience for donors, and create needed capacity as cell and gene therapy industry expands.

This position implements and oversees quality systems and activities at the NMDP Seattle Collection Center. Provides advice and guidance to facility management; manages applicable site certifications and registrations; manages audits and inspections of facility; oversees quality control activities; leads CAPA investigations and oversees implementation; oversees change control implementation and manages approved variances; performs quality data analysis and reporting; contributes to staff training in quality and compliance matters.

ACCOUNTABILITIES:

Quality Assurance Oversight:

  • Ensures facility operations are conducted in compliance with all applicable regulations and standards.
  • Provides guidance to operations management and staff regarding regulatory and quality system requirements.
  • Leads and oversees CAPA activities; works closely with QA Complaints and Investigations team to ensure timely investigation and resolution of problems and complaints.
  • Oversees change control implementation and manages approved variances.
  • Determines immediate and short-term remedial actions when problems/incidents or deviations occur.
  • Oversees Seattle site supplier qualification process and monitors/reviews approved supplier list.
  • Approves site SOPs and related documents; approves validation plans and reports.
  • Compiles, analyzes, and provides reports on quality systems functions and metrics.

Audits and Inspections:

  • Prepares for, hosts, and responds to audits and inspections of Seattle facility.
  • Prepares and leads site through CLIA accreditation process.

Training:

  • Develops and delivers quality/compliance training; contributes to process improvements with site specific input.
  • Ensures site personnel training and competency records are complete, accurate, and up to date.

Quality Control:

  • Oversees, monitors, and reviews Quality Control activities and records.

REQUIRED QUALIFICATIONS:

Knowledge of:

  • Quality systems and quality management, including QA and QC functions.
  • Apheresis and cell therapy applications.
  • FDA Biologics, Drug and Tissue regulations (including GMP/GTP), HIPAA, and other applicable regulatory requirements.
  • CLIA requirements for high complexity testing.

Ability to:

  • Demonstrate excellent oral and written communication and advanced interpersonal collaboration skills.
  • Effectively interact with inspectors and auditors.
  • Solve complex problems making timely and sound decisions.
  • Exercise independent judgement utilizing appropriate resources.
  • Handle multiple issues with flexibility and appropriate prioritization.
  • Exhibit strong customer service skills
  • Must exemplify our Be the Match Standard


Education and/or Experience:

  • Bachelor's degree, biomedical or scientific field preferred.
  • At least 10 years progressively responsible quality management experience in regulated environments.
  • At least 2 years experience with development and execution of validation plans and protocols for medical and/or laboratory equipment.
  • Experience hosting and/or performing quality audits/inspections.

PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)

  • ASQ/RAC/Exemplar certification.
  • ASCP certification.
  • Experience successfully leading CLIA or similar accreditation efforts.






Posted: 2019-10-31 Expires: 2019-11-29
Sponsored by:
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Sponsored by:
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Quality Lead, Collection Center - Based in Seattle

Be The Match
Seattle, WA 98104

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