Quality Management System

We at Global Life Science Hub are recruiting on behalf of an innovative biotech company based in New Jersey that is experiencing rapid growth after securing two FDA approvals and advancing a strong pipeline of assets. As the company moves from R&D to commercial-scale operations, they are significantly expanding their manufacturing and quality management capabilities, with plans to double their workforce within two years.

We are seeking a Quality Management System (QMS) Associate to join their team in New Jersey. In this role, you will support the implementation and maintenance of quality systems in compliance with GMP regulations, playing a vital part in ensuring product integrity and regulatory adherence throughout the manufacturing process.

Key Responsibilities:

• Support the development and execution of QMS procedures and processes to uphold GMP compliance.
• Assist in the review and management of quality documentation, including SOPs, deviation reports, and CAPAs (Corrective and Preventative Actions).
• Conduct internal audits and participate in regulatory inspections to support the company’s quality standards.
• Collaborate with cross-functional teams to promote continuous improvements in quality processes and ensure accurate and timely record-keeping.
• Assist in training and onboarding of new team members on QMS standards and practices.

Qualifications:

• Bachelor’s degree in a scientific field (Chemical, Biological, or Biochemical Sciences preferred) or equivalent experience.
• Minimum of 2 years of experience in a GMP-regulated environment, preferably within the pharmaceutical or biotech industry.
• Familiarity with quality systems, documentation practices, and basic GMP compliance requirements.
• Strong attention to detail, excellent organizational skills, and the ability to work collaboratively in a team-focused environment.

This is an exceptional opportunity to join a pioneering biotech company in New Jersey in a pivotal role that contributes directly to quality and compliance as the company expands through 2030.