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Quality Assurance, CQV lead

10 hours, 27 minutes ago
United States
Full-time
Lead
QA Engineer
Quality Assurance and Testing
Apply Now
Telix Pharmaceuticals

Telix Pharmaceuticals

Telix Pharmaceuticals is a global biopharmaceutical firm dedicated to the development and commercialization of diagnostic and therapeutic products that utilize targeted radiation, aiming to enhance treatment decisions and provide personalized therapies...

Pharmaceuticals
201-500
Founded 2015
View All Jobs 31

Description

  • Provide Quality Assurance oversight for commissioning, qualification, validation, and operational-readiness activities across U.S. manufacturing sites.
  • Review and approve validation lifecycle documents, including Validation Master Plans, risk assessments, protocols, reports, and qualification records.
  • Ensure facility startup, expansion, and remediation activities comply with cGMP requirements, including applicable 21 CFR Parts 210, 211, and 212.
  • Apply risk-based CQV approaches and support quality-system implementation for transition to routine GMP operations.
  • Review and approve CQV-related deviations, investigations, CAPAs, change controls, and quality risk assessments.
  • Partner with Engineering, Validation, Manufacturing, Quality Control, IT, and Regulatory Affairs to deliver project execution and GMP readiness.
  • Monitor project milestones, validation deliverables, and site-readiness metrics; escalate compliance and execution risks.
  • Support technology transfers, manufacturing readiness, site activation, and handoff to site Quality Assurance and Quality Control teams.
  • Lead readiness for regulatory inspections and internal or customer audits related to facility startup and validation.
  • Coordinate contractors, validation consultants, engineering firms, and service providers supporting CQV activities.

Requirements

  • Bachelor’s degree in Pharmacy, Chemistry, Biochemistry, Engineering, Microbiology, Life Sciences, or a related scientific discipline; advanced degree preferred.
  • 5+ years of experience in Quality Assurance, Validation, Engineering Quality, or CQV within the pharmaceutical, biotechnology, or radiopharmaceutical industry.
  • 5+ years of direct experience supporting CQV activities for GMP facilities and manufacturing systems.
  • Experience reviewing and approving Validation Master Plans, User Requirement Specifications, Design Qualification, IQ/OQ/PQ protocols, risk assessments, and validation reports.
  • Technical understanding of manufacturing, quality, and regulatory requirements.
  • Experience writing and reviewing SOPs.
  • Knowledge of applicable cGMP requirements, including 21 CFR Parts 210, 211, and 212.
  • Willingness and ability to travel more than 75% across U.S. manufacturing sites, including extended stays of several weeks.
  • English proficiency.
  • Strong communication, collaboration, adaptability, integrity, and results-oriented problem-solving skills.

Benefits

  • Competitive salary.
  • Annual performance-based bonus.
  • Equity-based incentive program.
  • Generous vacation time.
  • Paid wellness days.
  • Learning and development support.
  • Hybrid and remote work options.

Interested in this position?

Apply directly on the company website

Apply Now

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