• QMS Supervisor - Biologics Manufacturing

    Astrix Technology (New Brunswick, NJ)


    QMS Supervisor - Biologics Manufacturing

     

    Quality Assurance

     

    Middlesex County, NJ, US

    Pay Rate Low: 90000 | Pay Rate High: 105000

    + Added - 03/10/2025

     

    Apply for Job

     

    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_

    _LI-DNP_

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.