Quality Assurance Professional (Biologics)

TL;DR

Quality Assurance Professional (Biologics): Ensuring product and process compliance with GMP and regulatory standards for Cell Therapy and Biologics operations with an accent on deviation management and batch record review. Focus on leading complex investigations, implementing CAPAs, and maintaining audit readiness in a highly regulated manufacturing environment.

Location: Onsite in Portsmouth, NH, USA

Company

A global leader in life sciences, manufacturing medicines across more than 30 sites worldwide.

What you will do

• Ensure compliance with GMP, regulatory requirements, and internal quality standards.
• Review and approve batch records, protocols, reports, and quality documentation.
• Lead or support deviation investigations, root cause analysis, and CAPA implementation.
• Provide on-the-floor QA support to manufacturing and operations teams.
• Participate in internal, client, and regulatory audits and inspections.
• Coordinate quality-related projects, managing timelines and mitigating risks.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• Must be based in or able to work onsite in Portsmouth, NH.
• Strong knowledge of GMP and quality systems.
• Experience with deviations, investigations, CAPAs, and change controls for mid-level roles.
• Ability to follow SOPs and maintain strict data integrity.
• Familiarity with quality systems such as TrackWise, Veeva, or LIMS.

Nice to have

• 3–7+ years of experience in QA within a GMP-regulated industry.
• Project management experience for coordinating cross-functional efforts.

Culture & Benefits

• Global connection across 30+ sites and five continents.
• Core values based on Collaboration, Accountability, Excellence, Passion, and Integrity.
• Commitment to diversity, equity, and equal employment opportunities.
• Opportunity to contribute to breakthrough therapies that improve millions of lives.