Senior Consultant, Quality and Compliance

Responsibilities

• Independently establish and execute sponsor oversight programs for clinical trials, including CRO qualification, ongoing performance monitoring, and risk-based quality oversight aligned with ICH E6(R3).
• Serve as the independent quality liaison between client sponsors and CROs, central labs, IRT/RTSM vendors, e COA/e PRO providers, central imaging vendors, bioanalytical labs, and clinical supply CMOs.
• Author and approve quality agreements with clinical vendors; review and approve clinical vendor SOPs, validation documentation, and oversight plans before study start.
• Drive direction of the clinical quality function within client organizations — establish the quality oversight model, define escalation pathways, and align sponsor and vendor responsibilities.
• Independently plan, conduct, and report GCP audits, including investigator site audits, CRO/vendor system audits, TMF audits, clinical database audits, and for‑cause audits.
• Lead pre‑approval inspection (PAI) readiness and BIMO inspection preparation for sponsor clinical sites and key vendors; conduct mock inspections.
• Author audit reports with defensible findings, regulatory citations, and severity classifications; track CAPA commitments to closure.
• Build and maintain audit programs (risk‑based audit plans, annual schedules, audit metrics) for client sponsors.
• Review and approve clinical trial documents prior to use — protocols and amendments, ICFs, IB updates, monitoring plans, data management plans, statistical analysis plans, and clinical study reports — for GCP compliance and inspection‑readiness.
• Oversee TMF quality: review TMF completeness, contemporaneousness, and ALCOA+ compliance; advise on e TMF system configuration, indexing, and QC processes.
• Approve essential documents for clinical trial start‑up, including site selection packages, regulatory submissions support documentation, and IRB/EC correspondence.
• Lead investigations into serious GCP issues including protocol deviations of significance, data integrity concerns, informed consent issues, IP accountability discrepancies, and suspected fraud or misconduct.
• Author and approve CAPAs arising from audits, inspections, and quality events; ensure effectiveness checks are designed and executed.
• Advise client sponsors on quality issue escalation, including determination of reportability to regulatory authorities and IRBs/ECs.
• Provide quality input on regulatory submissions — IND, IMPD, CTA, NDA/BLA/MAA clinical modules — and represent the quality function during regulatory authority interactions.
• Lead client inspection support during FDA BIMO, EMA, MHRA, or other Health Authority inspections of sponsors, sites, or vendors.
• Maintain current knowledge of evolving GCP regulations and guidance (ICH E6(R3), ICH E8(R1), FDA decentralized clinical trial guidance, EU CTR, ICH E2A/E2B, 21 CFR Parts 11/50/54/56/312/812) and translate changes into actionable client recommendations.
• Independently manage multiple concurrent client engagements; serve as the senior quality point of contact and represent Syner‑G at client governance and steering committee meetings.
• Expand existing accounts by identifying additional quality gaps and proposing scope extensions; support proposal development and SOW authorship for new GCP work.
• Contribute to Syner‑G's GCP service offering — develop reusable templates, audit checklists, training content, and thought‑leadership materials.

Requirements

• Bachelor's degree required in life sciences, chemistry, pharmacy, nursing, or related discipline
• Advanced degree (MS, Pharm D, Ph D, or MPH) preferred
• Professional certification valued: RQAP‑GCP, SQA, ACRP‑CP, or equivalent
• Minimum 10 years of progressive experience in Gx P‑regulated environments, with at least 8 years of dedicated GCP experience in a sponsor, CRO, or consulting setting
• Demonstrated experience as a lead clinical quality auditor across investigator sites, CROs, central labs, and clinical vendors — minimum 25 GCP audits led independently
• Direct experience supporting at least one FDA BIMO inspection or equivalent EMA/MHRA GCP inspection of a sponsor or investigator site
• Hands‑on experience implementing and operating risk‑based quality management (RBQM) programs aligned with ICH E6(R2) or E6(R3)
• Experience across multiple clinical phases (Phase 1 through Phase 3 at minimum); Phase 4 / post‑marketing surveillance experience valued
• Experience supporting virtual or emerging biotech sponsors strongly preferred — including standing up clinical quality functions from scratch and operating with lean internal resources
• Subject matter expertise in ICH E6(R2)/E6(R3), ICH E8(R1), ICH E9, and ICH E2A/E2B(R3)
• Working command of 21 CFR Parts 11, 50, 54, 56, 312, and 812; EU Clinical Trials Regulation (EU 536/2014); EMA reflection papers on risk‑based quality management and computerized systems
• Fluency with e TMF systems (Veeva Vault Clinical, Phlexglobal, or equivalent), e CRF/EDC platforms (Medidata Rave, Veeva CDMS, or equivalent), CTMS, and IRT/RTSM platforms
• Confident application of risk management methodology (ICH Q9(R1)) to clinical risk assessment, including critical‑to‑quality factor identification and quality tolerance limits.
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