The Senior Specialist, External Quality position at 39med is a fully remote role focused on ensuring compliance with regulatory requirements for pharmaceutical products. The candidate will oversee batch release processes and collaborate with internal and external stakeholders to maintain quality standards
Job Summary
The role serves as a Qualified Person responsible for certifying batches of 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 thorough knowledge of Quality Systems.
The position involves managing deviations, coordinating investigations, and acting as an owner for change controls within external manufacturing partnerships.
Matching Summary
Match Score: 85
The Senior Specialist, External Quality position at 39med is a fully remote role focused on ensuring compliance with regulatory requirements for pharmaceutical products. The candidate will oversee batch release processes and collaborate with internal and external stakeholders to maintain quality standards.
Skills & Requirements
Must-have
Qualified Person certification for EU market
5 years pharmaceutical industry experience
Global GMP and regulatory requirements knowledge
Batch release responsibility for finished goods
Experience with Veeva, SAP COMET, CLUE systems
Nice-to-have
Ability to lead cross-functional matrixed teams
Strong problem-solving skills with minimal guidance
Experience in New Product Introduction activities
Effective stakeholder collaboration and influence
Active listening and clear communication skills
Key Requirements
Minimum four-year degree in Science or Engineering
Minimum 5 years relevant pharmaceutical/biotech experience
Proficiency with digital systems like Veeva and SAP COMET