QE lead

Bahwan Cybertek Group

• $110K — $130K *
Natick, MA 01760In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 10+ years of testing experience in life sciences fields
  • Strong knowledge of GxP regulations (GMP/GLP/GCP)
  • Hands-on experience with CSV testing and documentation
  • Proficient in using JIRA and HP ALM for test management
  • Familiarity with test automation frameworks for validation
  • Experience in dealing with deviations, CAPAs, and change control
  • Background in pharma, biotech, or medical device industries preferred

Responsibilities

  • Lead quality assurance efforts for validated systems
  • Plan and execute test strategies and defect tracking
  • Create and maintain audit-ready test documentation
  • Collaborate with client QA, IT, and business teams
  • Bridge communication between offshore teams and onsite stakeholders
  • Ensure timely delivery of project milestones
  • Oversee test automation initiatives for improved efficiency

Benefits

  • Opportunities for professional development and training
  • Flexible working arrangements
  • Collaborative work environment with a diverse team
  • Exposure to cutting-edge technologies in life sciences
  • Potential for career growth within the organization
Full Job Description
Role description

  • QR lead with 10+ years of testing experience and for a life sciences customer, ensuring quality across validated systems.
  • Strong working knowledge of GxP (GMP/GLP/GCP) regulations and compliance requirements.
  • Hands-on experience with CSV testing, including IQ/OQ/PQ documentation and execution.
  • Manage test planning, execution, and defect tracking using JIRA and HP ALM.
  • Exposure to test automation frameworks to drive efficient regression/validation cycles.
  • Coordinate with client QA, IT, and business stakeholders to align on timelines and deliverables.
  • Ensure test scripts, traceability matrices, and validation reports are audit-ready.
  • Experience with deviations, CAPAs, and change control in validated environments.
  • Bridge offshore delivery teams with onsite client expectations; strong stakeholder management.
  • Prior experience in pharma, biotech, or medical device domains preferred.
* Ladders Estimates

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