Senior Specialist, External Quality

29

Not specified; not specified; not specified
Fully remote
Qualified person certification for eu market
5 years pharmaceutical industry experience
Global gmp and regulatory compliance knowledge
The Senior Specialist, External Quality position at 29 is a fully remote role focused on ensuring compliance with regulatory standards for the manufacture and release of pharmaceutical products. The ideal candidate will have extensive experience in Quality Assurance within the pharmaceutical or biotechnology industries and will be responsible for overseeing batch releases and quality improvement initiatives

Job Summary

  • The role serves as a Qualified Person responsible for certifying Finished Good products for the EU market under European laws.
  • Candidates must possess at least five years of relevant experience in the pharmaceutical or biotechnology industry with deep knowledge of global GMP requirements.
  • The position involves leading quality improvement projects, managing deviations, and acting as an owner for change controls within a matrixed organization.

Matching Summary

Match Score: 85

The Senior Specialist, External Quality position at 29 is a fully remote role focused on ensuring compliance with regulatory standards for the manufacture and release of pharmaceutical products. The ideal candidate will have extensive experience in Quality Assurance within the pharmaceutical or biotechnology industries and will be responsible for overseeing batch releases and quality improvement initiatives.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • Qualified Person certification for EU market
  • 5 years pharmaceutical industry experience
  • Global GMP and regulatory compliance knowledge
  • Batch release responsibility for finished goods
  • Deviation management and root cause analysis
  • Change control ownership and approval
  • Veeva, SAP COMET, CLUE proficiency

Nice-to-have

  • New Product Introduction support experience
  • Cross-functional team leadership skills
  • External partner site visit capability
  • Quality improvement project initiation
  • Strong stakeholder collaboration abilities
  • Adaptability to evolving business needs

Key Requirements

  • Minimum four-year degree in Science or Engineering
  • Minimum 5 years relevant pharmaceutical/biotech experience
  • Thorough knowledge of Quality Systems and QC/QA
  • Proficiency with Veeva applications and SAP COMET
  • Ability to work independently with minimal direction

Work Rights

Not specified

Tailored Resume

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