Senior Specialist GCP QA

@ Quotient Sciences

About Quotient Sciences

Quotient Sciences: Molecule to Cure. Fast. We accelerate drug development by integrating formulation development, clinical testing, data sciences, and manufacturing into one seamless process. Our proprietary platform, Translational Pharmaceutics®, shortens timelines by 9–12 months on average.

Arcinova, our specialist arm located in Reading and Alnwick, UK, delivers end-to-end drug substance and early drug product services including bioanalysis and radiolabeling—streamlining early development from candidate selection to proof of concept.

Why Join Us?

Every day counts in bringing new medicines to patients. Join over 1,000 experts across the US, UK, and beyond who unite scientific rigor, agility, and a results-driven culture.

The Role: Senior Specialist GCP QA

Responsibilities:

• Drive and support the Site Quality Management System Metrics.
• Optimize and implement Quality Assurance (QA) systems.
• Communicate compliance requirements and serve as a regulatory role model.
• Manage and support GCP regulatory inspections, internal audits, and GDP trainings.
• Oversee Quality Management System through Veeva and guide corrective actions.
• Coach and mentor QA clinical personnel and ensure alignment across teams.

Qualifications:

• Bachelor’s Degree in a scientific field (Chemistry, Biology, or Pharmacology).
• Minimum 5 years in life sciences quality or regulated environments.
• Strong knowledge of Quality Management Systems, GCP, ICH Guidelines, and related regulations.
• Experience in conducting audits and hosting regulatory inspections.
• Excellent communication, mentoring, and problem-solving skills.

Additional Information:

• Candidates must be 18+ and not debarred by the FDA.
• Quotient Sciences is committed to diversity, equity, and inclusion.

Key skills/competency

• Quality Assurance
• GCP
• Regulatory Inspections
• Internal Audits
• Veeva QMS
• Risk Management
• Life Sciences
• Compliance
• GDP Training
• Mentoring