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 - $105K

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!

INDBH
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