QMS Supervisor - Biologics Manufacturing Job at Astrix, Middlesex County, NJ

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  • Astrix
  • Middlesex County, NJ

Job Description

We are seeking an experienced Quality Systems/QMS Supervisor to lead quality management initiatives within a biologics manufacturing environment. The ideal candidate will bring strong expertise in both upstream and downstream processes, a proven track record in investigations and validations, and the ability to drive compliance and continuous improvement in a GMP-regulated setting. This is a great opportunity to join a dynamic biopharmaceutical company with a global footprint in both R&D and manufacturing.

Type: Direct Hire

Rate: $90K - $100K

Location: Middlesex County, NJ (100% onsite)

Shift: Monday to Friday (9:00 to 5:30 PM), with flexibility to work extended hours.

Responsibilities:

  • Oversee all QMS activities including investigations, CAPA, documentation control, and report writing.
  • Lead and manage PPQ and cleaning validation projects to support product and process integrity.
  • Ensure ongoing compliance with FDA, EMA, ICH, and other global regulatory standards.
  • Provide leadership and mentorship to quality team members; foster collaboration across manufacturing, validation, and regulatory teams.
  • Support audits, inspections, and regulatory reviews, ensuring readiness and robust documentation.
  • Drive continuous improvement initiatives, strengthening the QMS and aligning with industry best practices.

Qualifications:

  • Bachelor’s degree in Life Sciences or a related field.
  • 6+ years of biologics manufacturing experience, with at least 3 years focused on QMS leadership.
  • In-depth knowledge of upstream and downstream biologics processes.
  • Demonstrated experience in investigation report writing, CAPA, and documentation management.
  • Strong background in PPQ, cleaning validation, and global GMP/regulatory compliance.

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

Job Tags

Monday to Friday, Shift work,

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