Associate Director, Global GCP QA

Job not on LinkedIn

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $165k - $210k / year

⏰ Full Time

🟠 Senior

🔧 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

• Independently provide QA oversight for assigned clinical programs • Ensure clinical phase and China clinical programs comply with applicable health authority regulations and guidelines • Review key clinical and regulatory submission documents, including IND/NDA documents • Identify and document vendor risks related to study compliance, data integrity, and participant safety • Review clinical trial documentation for data integrity and GCP compliance • Manage quality events and CAPAs, escalating significant risks appropriately • Prepare quality metrics and trend analyses for management review • Create, maintain, and improve quality SOPs, manuals, templates, process maps, and approval flows • Provide quality guidance to clinical functions and implement fit-for-purpose GCP procedures • Support continuous improvement initiatives and quality improvement projects • Promote a culture of quality through communication, training, and stakeholder engagement • Report key quality metrics to leadership • Lead audits of studies, internal processes, investigator sites, vendors/CROs, TMFs, and CSRs • Review audit findings and ensure effective root cause analysis and CAPAs • Support GCP vendor qualification and oversight • Evaluate and mitigate GCP compliance risks • Support inspection readiness and lead assigned inspection workstreams • Support global regulatory authority inspections • Maintain current knowledge of agency and industry GCP trends, standards, and methodologies • Report to the Executive Director, Global GCP, QA

🎯 Requirements

• BS/MS or equivalent in a scientific discipline required • 8+ years of pharmaceutical/biotechnology experience • At least 4 years in a GCP QA lead auditor role • Prior experience supporting regulatory inspections (FDA, EMA, MHRA, NMPA, PMDA) • Expertise in ICH E6, E8, E2A-F, 21 CFR Part 11, EU Annex 11, and other global standards • Prior success executing QMS systems, including vendor management and system implementation • Working knowledge of EDMS and other document and data management platforms • Highly organized and detail-oriented, with the ability to manage multiple priorities • Exceptional 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 • Willingness to travel 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