QC Compliance Manager
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)
________________________________________
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
- 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, Cell&Gene, Vaccine experience or the equivalen t. nd/or CDMO experience strongly preferred
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
- 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
#LI-
#DI- Ref: #558-Scientific
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