Randstad Life Sciences US
Clinical Quality Compliance Lead
Randstad Life Sciences US, Cambridge, Massachusetts, us, 02140
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Clinical Quality Compliance Lead
role at
Randstad Life Sciences US .
The
Clinical Quality Compliance Lead
provides critical quality oversight to clinical trial delivery systems, ensuring operational and compliance excellence across the organization. This role maintains a state of control by implementing effective monitoring systems, managing systemic quality risks, and driving continual improvement aligned with global regulations (GCP/GVP). You will act as a key strategic partner to the Head of GCP Quality Compliance, managing major quality events and building functional capabilities.
Must Have Experience
BS Degree
7+ years Global Pharma experience
Expertise in GCP Quality/Compliance
Global GCP/GVP regulations (FDA, EU, MHRA, PMDA, ICH)
Leading regulatory inspections & managing global remediation activities
Managing complex organizational compliance issues & leading global, cross‑functional projects
Responsibilities Inspection Readiness & Hosting
Lead and implement the strategic inspection readiness program for the clinical trial delivery system.
Host major GCP inspections, providing strategic direction to SMEs and relevant functions (e.g., Global Development, Regulatory Affairs).
Maintain robust, transparent communication regarding inspection progress, risks, and escalations.
Provide guidance for non‑GCP inspections (e.g., GVP, GMP).
Response & CAPA Management
Lead and manage the official inspection response process, ensuring thorough root cause analysis, adequate response content, and timely submission.
Oversee the entire lifecycle of inspection CAPA's, ensuring timely closure and effectiveness checks.
Quality System Leadership
Lead and provide quality leadership for complex quality investigations and deviations impacting clinical systems.
Act as the SME for core quality processes, including deviation management, quality investigations, CAPA oversight, and change control.
Develop and promote lessons learned and knowledge management from regulatory inspections and internal investigations.
Develop and monitor key Quality Indicators (KPIs/KQIs) to understand the health of the quality system (e.g., risk registers).
Proactively identify emerging regulatory risks and provide strategic and tactical direction for mitigation.
Lead cross‑functional continual improvement projects and review/approve controlled procedures.
Qualifications
Education: BSc in a scientific or allied health/medical field (or equivalent).
Experience: Minimum 7 years of increasing responsibility in the global pharmaceutical industry (e.g., Clinical Ops, Data Management), with at least 3 years dedicated to GCP Quality/Compliance.
Advanced knowledge of global GCP/GVP regulations (FDA, EU, MHRA, PMDA, ICH).
Demonstrated experience in hosting/leading regulatory inspections and successfully managing global remediation activities.
Proven ability to manage complex organizational compliance issues and lead global, cross‑functional projects.
Fluency in written and spoken English is required.
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Clinical Quality Compliance Lead
role at
Randstad Life Sciences US .
The
Clinical Quality Compliance Lead
provides critical quality oversight to clinical trial delivery systems, ensuring operational and compliance excellence across the organization. This role maintains a state of control by implementing effective monitoring systems, managing systemic quality risks, and driving continual improvement aligned with global regulations (GCP/GVP). You will act as a key strategic partner to the Head of GCP Quality Compliance, managing major quality events and building functional capabilities.
Must Have Experience
BS Degree
7+ years Global Pharma experience
Expertise in GCP Quality/Compliance
Global GCP/GVP regulations (FDA, EU, MHRA, PMDA, ICH)
Leading regulatory inspections & managing global remediation activities
Managing complex organizational compliance issues & leading global, cross‑functional projects
Responsibilities Inspection Readiness & Hosting
Lead and implement the strategic inspection readiness program for the clinical trial delivery system.
Host major GCP inspections, providing strategic direction to SMEs and relevant functions (e.g., Global Development, Regulatory Affairs).
Maintain robust, transparent communication regarding inspection progress, risks, and escalations.
Provide guidance for non‑GCP inspections (e.g., GVP, GMP).
Response & CAPA Management
Lead and manage the official inspection response process, ensuring thorough root cause analysis, adequate response content, and timely submission.
Oversee the entire lifecycle of inspection CAPA's, ensuring timely closure and effectiveness checks.
Quality System Leadership
Lead and provide quality leadership for complex quality investigations and deviations impacting clinical systems.
Act as the SME for core quality processes, including deviation management, quality investigations, CAPA oversight, and change control.
Develop and promote lessons learned and knowledge management from regulatory inspections and internal investigations.
Develop and monitor key Quality Indicators (KPIs/KQIs) to understand the health of the quality system (e.g., risk registers).
Proactively identify emerging regulatory risks and provide strategic and tactical direction for mitigation.
Lead cross‑functional continual improvement projects and review/approve controlled procedures.
Qualifications
Education: BSc in a scientific or allied health/medical field (or equivalent).
Experience: Minimum 7 years of increasing responsibility in the global pharmaceutical industry (e.g., Clinical Ops, Data Management), with at least 3 years dedicated to GCP Quality/Compliance.
Advanced knowledge of global GCP/GVP regulations (FDA, EU, MHRA, PMDA, ICH).
Demonstrated experience in hosting/leading regulatory inspections and successfully managing global remediation activities.
Proven ability to manage complex organizational compliance issues and lead global, cross‑functional projects.
Fluency in written and spoken English is required.
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