Senior Project Manager – Diagnostics Bioanalysis (GxP)

Role Details

• Location : Lawrenceville NJ

This is not a generic PM role.
Youve run diagnostics or bioanalysis programs inside regulated environments - and you know what Design Control actually means in practice.

If youve owned CLIA/CDx or GLP bioanalysis end-to-end this will feel familiar.

Who this role is for

• Youve led diagnostic or bioanalytical programs tied to clinical studies
• Youve worked inside GxP environments and dealt with audits DHFs and regulatory pressure
• Youve partnered with labs CROs QA and regulatory - not just internal teams
• You understand how diagnostics clinical timelines connect

Environment

• Highly regulated (GxP FDA CLIA ISO)
• Cross-functional: labs QA regulatory CROs
• Clinical diagnostics integration

What this role actually owns day-to-day

• Driving assay programs from design validation clinical use
• Managing GLP bioanalysis tied to clinical studies (PK/PD/ADA)
• Keeping Design Control clean (DHF traceability risk reviews)
• Working directly with CROs labs and vendors
• Staying audit-ready at all times

Key Responsibilities

• Run end-to-end diagnostic programs (IUO/CDx) across design verification transfer and CLIA validation
• Own Design Control execution - inputs/outputs DHF risk traceability reviews
• Manage GLP bioanalytical programs supporting clinical studies (PK/PD/ADA)
• Track assay timelines reagents data transfers and CRO deliverables
• Align diagnostics bioanalysis with clinical and regulatory milestones
• Lead vendor interactions (CROs CLIA labs IVD partners) - scope timelines escalations
• Drive audit readiness inspections and CAPA with QA teams
• Maintain compliance across QMSR (21 CFR 820) GLP CLIA/CAP ISO 13485 IVDR
• Provide clear updates to leadership with risks dependencies and mitigation

Must-Have Requirements (Non-Negotiable)

• 6 years in GxP-regulated environments (Diagnostics Bioanalysis or both)
• Hands-on Design Control experience (IVD/CDx or IUO assays)
• Direct experience with CLIA and/or GLP bioanalysis programs
• Strong working knowledge of:
  • 21 CFR 820 (QMSR)
  • GLP
  • CLIA/CAP
  • ISO 13485 / EU IVDR
• Proven track record managing cross-functional programs with labs QA regulatory and vendors