JVT Advisors

Sr QA Consultant

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Location: Cambridge, Massachusetts
Employment Type: Contract

Job Description

12+ Months

Job Duties: The primary focus of this role will be to provide organizational management and leadership for all Quality Assurance activities ensuring cGXP compliance for the organization. This person will work collaboratively and cross-functionally with the Manufacturing, Supply Chain, Technical Development and Clinical teams, among others to ensure compliance with and improvements to the Quality Management System.

Responsibilities:

  • Develop and implement Quality KPI’s aligned with our business objectives and communicate progress to the broader organization
  • Conduct Quality review of internal and external production documentation, including batch records, analytical records and any supporting documentation to ensure compliance with cGMP policies and procedures
  • Review and approve Standard Operating Procedures (SOPs), Change Controls, Validation Protocols/Reports, and Identify compliance gaps and proactively take steps to remediate, ensuring internal and external standards are met
  • Proactively identify compliance issues, investigate and propose solutions, and lead closure of deviations and completion of corrective and/or preventative actions
  • Take leadership role for all on-site inspections by regulatory agencies and partners; organize and train personnel regarding regulatory agency inspection readiness.

Qualifications:

  • BS degree in Chemistry, Biology, Quality Regulatory or relevant scientific area
  • Minimum 10+ years of Quality Assurance related experience in a cGXP regulated biotech or pharma environment with increasing responsibility.
  • Ability to conceptualize, organize, execute, analyze and lead cross-functional projects with a high degree of self-motivation
  • Excellent organizational skills and strong attention to detail

Trevor Hoffman

Technical Recruiter

Trevor recruits for JVT's Life Sciences and Technology Practices where he specializes in finding, screening, and placing top-tier industry innovators at companies across multiple markets and verticals.

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