Director, Global GCP QA

Job not on LinkedIn

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $225k - $285k / year

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 16%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Structure Networks, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2001

💼 Consulting

Consulting

Structure Networks, Inc. is a privately-held IT staff augmentation firm headquartered in Tustin, California. Founded in 2001, it is recognized as one of the fastest growing IT services firms in the United States, focusing on areas such as the Microsoft platform, network-centric technologies, application development, testing, ERP, and general IT consulting and staff augmentation services.

📋 Description

• Act as the primary GCP QA subject matter expert and point of contact for assigned early- and late-phase clinical and China clinical programs • Ensure clinical programs comply with applicable health authority regulations and guidelines • Provide quality oversight and review key clinical and regulatory submission documents, including IND/NDA documents • Own and implement the risk-based GCP audit and compliance strategy across the clinical portfolio • Establish GCP quality governance forums and provide compliance reports to senior leadership • Lead assessment and escalation of significant quality events, serious breaches, systemic trends, and critical and major CAPAs • Monitor adverse trends, manage issue trends, and make recommendations to management • Provide strategic oversight of CROs and other critical clinical vendors • Manage or mentor GCP QA employees, consultants, and contracted auditors • Represent GCP QA in governance committees and major program decisions • Assess and manage vendor-related risks affecting study compliance, data integrity, and participant safety • Review clinical trial documentation for data integrity and GCP compliance • Create, maintain, and improve quality SOPs, manuals, templates, process maps, approval flows, and the GCP QMS • Drive continuous improvement across Global QA processes • Partner with clinical functions to implement fit-for-purpose GCP procedures • Promote a culture of quality through communication, training, and stakeholder engagement • Report key quality metrics to leadership • Develop strategies and execute or lead routine and for-cause audits of studies, internal processes, investigator sites, vendors/CROs, TMFs, and CSRs • Approve audit findings, reports, root cause analyses, action plans, and audit CAPAs • Lead and oversee GCP-related vendor qualification and oversight • Evaluate and mitigate GCP compliance risks • Lead sponsor inspection readiness and regulatory inspection activities, including inspection strategy, front-room/back-room execution, and response development • Support global regulatory authority inspections and lead or support site and vendor inspection readiness • Maintain current knowledge of agency and industry GCP trends, standards, and methodologies

🎯 Requirements

• BS/MS or equivalent in a scientific discipline required • Advanced degree preferred • Auditor certifications and/or SQA RQAP credentials preferred • 10+ years of pharmaceutical/biotechnology experience • At least 7+ years in a GCP QA lead auditor role • Prior experience in Big Pharma preferred • Proven leadership supporting regulatory inspections, including FDA, EMA, MHRA, NMPA, and PMDA • Expertise in ICH E6, E8, E2A-F, 21 CFR Part 11, EU Annex 11, and other global standards • Prior success designing and executing QMS systems, including vendor management and system implementation • Working knowledge of EDMS and other document and data management platforms • GCP QA experience required • Ability to manage multiple priorities in a fast-paced, evolving environment • Exceptional leadership, project management, and communication skills • Ability to drive outcomes across matrixed teams and third parties • Strong strategic thinking and adaptability in a fast-paced, global environment • Travel required: up to approximately 50% depending on location

🏖️ Benefits

• Annual performance incentive bonus • New hire equity • Ongoing performance-based equity • Medical insurance • Dental insurance • Vision insurance • 401k match • Unlimited PTO • Paid holidays, including winter shutdown • Remote work option • Hybrid model if onsite • Equal-opportunity employment