QC Compliance Manager

Job Title: QC Compliance Manager - Biologics / Biosimilars
Location: Greater Princeton, NJ area
Employment Type: Direct Hire (Onsite)
Schedule: Full-Time, Day Shift (M-F, 8-5 with flexibility)
Compensation: $94,000-$124,000 (depending upon experience)
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Role Overview

• Join a rapidly growing biologics CDMO operation and take a leading role in shaping QC compliance programs supporting biologics and biosimilar development and manufacturing.
• Shape and elevate QC compliance frameworks.
• Work with advanced biologics platforms and global-quality operations.
• Thrive in a dynamic, startup-like environment with significant opportunities for impact and visibility

Must-Have Qualifications

• Deep knowledge of Quality Management Systems (QMS), cGMP, data integrity, and regulatory expectations
• Proven experience leading internal laboratory audits, compliance investigations, and managing OOS, deviations, CAPAs, and change controls
• Strong technical writing skills (SOPs, protocols, validation documents, reports)
• Hands-on familiarity with analytical instruments and systems: HPLC, UPLC, LIMS, TrackWise, etc.
• B.S. in Chemistry, Biochemistry, Biotechnology, or related discipline (advanced degree preferred)
• 5-7+ years in a biopharmaceutical QC environment, including 1-3 years focused on compliance, auditing, and investigations
• Biologics, biosimilars, and/or CDMO experience strongly preferred

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Full Scope of Responsibilities

• Quality Control Oversight: Manage QC workflows to ensure compliance with regulatory and internal quality standards
• Equipment & System Management: Review logbooks, audit trails, and oversee calibration, PM, and qualification activities
• Equipment Qualification: Collaborate cross-functionally on URS, SLIA, and qualification protocol development and execution
• Non-Conformance Handling: Drive investigations, implement CAPAs, and maintain strong change control processes
• Audits & Inspections: Conduct internal audits; support external audits and regulatory inspections
• Method Transfer & Validation: Lead development of method transfer/validation protocols and reports; support execution with lab leaders
• Training Leadership: Design and maintain training curricula and training records in the QMS
• Team Leadership: Supervise, coach, and develop QC compliance staff
• Regulatory Intelligence: Monitor and apply updates to regulatory and industry standards in biologics
• Data Review & Reporting: Analyze compliance metrics and present updates in cross-functional quality meetings

Key Responsibilities (High-Impact Focus)

• Lead internal QC lab audits ensuring compliance with cGMP, data integrity, and equipment qualification standards
• Manage all aspects of Stability and Sample Receipt programs
• Oversee and conduct investigations for OOS, deviations, CAPAs, and change controls
• Author and review compliance documentation: URS, protocols, reports, training records
• Train, guide, and mentor compliance officers and QC technicians

System One, and its subsidiaries including Joul, 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.

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Ref: #558-Scientific