• QC Compliance Manager

    System One (Pennington, NJ)


    Job Title: QC Compliance Manager

     

    Type: Direct Hire

     

    Hours: Full-Time, Day Shift (Standard Business Hours) M-F 8am-5pm

    Responsibilities:

    + Lead internal lab audits to ensure data integrity, equipment qualification, and regulatory compliance

    + Manage and maintain Stability and Sample Receipt programs

    + Oversee investigations into OOS, deviations, and manage CAPAs and change controls

    + Author and review compliance documentation (URS, protocols, training records, etc.)

    + Provide training and mentorship to compliance officers and technicians

    + Quality Control Oversight: Oversee laboratory processes and workflows to ensure they meet quality and compliance standards. Develop and manage Stability and Sample Receipt programs.

    + Equipment Management: Review equipment logbooks, audit trails, and ensure proper preventative maintenance and calibration of laboratory equipment.

    + Equipment Qualification: Collaborate across departments to author/review URS, SLIA, and qualification protocols for lab instruments and systems.

    + Non-Conformance Handling: Investigate and resolve compliance issues such as OOS (Out of Specification) results and deviations. Initiate and manage change controls and implement CAPAs.

    + Audits & Inspections: Conduct regular internal audits and inspections to ensure compliance with cGMP, FDA, and other applicable regulatory standards.

    + Technology Transfer & Method Validation: Lead protocol/report writing for analytical method transfer and validation. Support execution alongside Lab Managers.

    + Training Program Oversight: Design and implement training programs. Maintain training records and create department training curricula within the Quality Management System.

    + Team Leadership: Supervise and mentor lab compliance staff including officers and technicians.

    + Regulatory Compliance Monitoring: Remain up to date on industry and regulatory changes and ensure ongoing lab compliance with evolving standards.

    + Data Review & Reporting: Analyze operational and compliance data to identify trends and drive improvements. Present findings in internal and global quality meetings.

    + Other duties as assigned.

    Requirements:

    + Bachelor’s degree in Chemistry, Biochemistry, Biotechnology, or a related field (advanced degree preferred)

    + Minimum 5-7 years in biopharmaceutical lab environments; with at least 1-3 years in laboratory compliance, audits, and investigations

    + Experience in the Biopharmaceutical or Biotechnology industry (CDMO experience a plus)

    + Strong knowledge of Quality Management Systems (QMS), including cGMP and compliance audits

    + Experience leading and conducting internal lab audits and investigations (OOS, deviations, CAPAs)

    + Technical writing experience is required – SOPs, protocols, reports, investigations

    + Experience with analytical instruments and software systems (HPLC, UPLC, LIMS, TrackWise, etc.)

     

    System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

     

    System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

     

    Ref: #558-Scientific

     

    System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

     

    System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.