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Quality Control Validation Senior Lead

PR/156181_1712220949
  • US$90000 - US$100000 per annum
  • Massachusetts
  • Permanent

Join a leading force in the contract manufacturing and pharmaceutical development industry, which operates on a global scale in partnership with leaders in the pharmaceutical and biotechnology field.

This organization is at the forefront of innovation, having played a part in countless product development and commercialisation efforts throughout their decades-long heritage. Currently, they are looking to appoint a Quality Control Validation Senior Lead, a role that presents a great opportunity to contribute to a top-tier Quality Control (QC) computer systems validation team.

The ideal candidate will play a pivotal role in the day-to-day administration, validation, and qualification of laboratory instrumentation and software, ensuring the highest standards of quality and efficiency.

This is a hybrid position with the nearest site location in Portsmouth, New Hampshire.


Your Role as Quality Control Validation Sr Lead:

  • Lead and complete QC analytical instrument and software validation deliverables, including the drafting of GMP procedures, validation documents, and execution of test scripts.
  • Serve as a guiding force for the team, overseeing the writing, reviewing, and approval of QC analytical instrument and software validation project plans.
  • Drive projects to successful, on-time completion while working collaboratively with QC leaders to meet predefined timelines.
  • Manage software administration tasks such as converting test methods and other documents into instrument computer system software.
  • Ensure system integrity through user and application software administration on Enterprise systems, including audit trail reviews and validation maintenance.
  • Implement engineering controls in QC Laboratories to uphold data integrity and IT/OT security, participating as a subject matter expert during inspections and audits.
  • Oversee all aspects of Quality Management System (QMS) processes including Change Control, Deviations, CAPAs, and Task Writes, ensuring compliance with internal SOPs, FDA, and cGMP regulations.



Experience and Qualifications for the Quality Control Validation Senior Lead Role:

  • A Bachelor's Degree in Microbiology, Biochemistry, Chemistry, Engineering, Computer Science, or related fields.
  • Strong and demonstratable experience in Analytical Laboratory Computer Systems and Instrument Validation.
  • Hands-on administration experience with local systems such as TOC and Softmax.
  • A strong understanding of regulatory requirements and a commitment to maintaining data integrity.
  • Experience with the SDLC lifecycle, working in Quality Control Laboratories, and familiarity with GMP Quality Systems like TrackWise, LIMS, LES, Empower, and MODA.



This is a position that allows you play a significant part in pharmaceutical development and to impact patient lives worldwide. Apply now for immediate consideration or reach out directly to discover more opportunities in the quality and validation sector.

Mollie Richmond Associate Consultant, Biometrics

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