Quality Assurance Manager

VitaCyte is a leading manufacturer of purified-defined bacterial collagenase and associated protease enzymes for enzyme-mediated cell isolation and other biotherapeutic applications. The company has established a Quality Management System (QMS) to comply with ISO-9001 and aligned with industry standards and regulations.

Job Purpose Maintain the QMS to ensure compliance with ISO 9001 and applicable regulatory standards in a state of inspection readiness under the direction of the Director of Quality Assurance.Duties & ResponsibilitiesEnsures VitaCyte personnel comply with an ISO 9001 certified QMS and applicable regulatory requirements.Owns and delivers the training program for the site while ensuring compliance with the QMS and applicable regulatory requirements. Management of the training program may include facilitation of course creation & revision, course instruction & remediation, coordination of the training schedule, maintaining employee training files, and periodic metrics trending and reporting.
Owns the site inspection readiness program, which includes periodic self-assessments, customer audits, and external agency inspections. Management of the inspection readiness program includes but is not limited to the facilitation of inspection planning, executing, reporting, appropriate escalation/notification to management, closing & executive summaries, and tracking and evaluating the effectiveness of any performed remediation by the audited party.
Owns and executes the vendor management program for the site while ensuring compliance with the QMS and applicable regulatory requirements. Vendor management may include negotiating terms of Quality Assurance Agreements, creation & revision of the vendor management procedure & risk classification procedure, vendor inspections, vendor classifications, onboarding, performance monitoring, metric reporting, and termination.
Owns the non-conformance management process, which includes deviation, corrective actions, root cause investigations, and documentation management
Support equipment and facility maintenance and calibration records
Support change management processes and records

1. Qualifications
   • Education/Experience
     • Bachelor’s Degree in Chemistry, Biochemistry, Biology, or Biotechnology, or related field
     • Minimum 3-years experience working with a quality management system
     • Knowledge of applicable standards and regulations (ex. ISO 9001, ICH Q7, 21 CFR Part 210/211)
     • Maintaining ISO certification is preferred.
     • Experience with eQMS and/or CMMS software preferred.
     • Auditing experience preferred.
   • Skills/Abilities
     • Comfortable working in a laboratory environment including lab safety, general chemical knowledge, clean room attire and recording results in controlled documents
     • Strong computer skills including comfort using web-based software tools
     • Strong documentation, interpersonal, communication and problem-solving skills while working in a team environment
     • Average physical strength and ability to stand for long periods
2. Benefits
   • Full time, permanent position including a comprehensive family medical benefit package and participation in an employer matched 401K plan.
   • Salary is commensurate with experience.