job summary: Clinical Quality Compliance Lead Cambridge, MA (2 days per week onsite) 12 Month Contract | w2 only 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 Degree7+ years Global Pharma experience Expertise in GCP Quality/ComplianceGlobal GCP/GVP regulations (FDA, EU, MHRA, PMDA, ICH)Leading regulatory inspections & managing global remediation activitiesManaging complex organizational compliance issues & leading global, cross-functional projects location: Cambridge, Massachusetts job type: Contract salary: $115 - 125 per hour work hours: 9 to 5 education: Bachelors responsibilities: Will be the Subject Matter Expert (SME) for Clinical Quality Compliance, focusing on: 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 CAPAs, 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. Monitoring & Strategy: 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. skills: Quality Assurance, ICH Regulations, Inspection Management, Good Pharmacovigilance Practices (GVP), Corrective and Preventive Actions (CAPA), Pharmaceuticals and Medical Devices Agency (PMDA), European Medicines Agency (EMA), Food and Drug Administration (FDA) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.