GCP Quality Assurance Manager

GCP Quality Assurance Manager Buckeye Global Alameda, CA Job Details Temporary | Contract $80 - $95 an hour 2 hours ago Qualifications Quality control corrective actions Regulatory inspections Stakeholder engagement Management Clinical compliance checks Clinical research audit management Quality control audit Vendor compliance audits Supplier audits ICH guidelines Quality assurance within pharmaceutical industry Regulatory readiness in healthcare Clinical quality assurance standards Oncology Stakeholder relationship building FDA regulations Audit support Stakeholder management

Full Job Description Job Details:

Job Title:

GCP Quality Assurance Manager Job Duration:

06 conths contract with FT conversion for local candidates Job location: Alameda California 94502 (Fully Onsite)

Shift:

8AM - 5

PM PST Summary:

Join a growing clinical development organization seeking an experienced GCP Quality Assurance professional to support global clinical trials, inspection readiness, and quality oversight activities. What You'll Do Lead and execute GCP audits of investigator sites, CROs, vendors, and internal processes Support inspection readiness and regulatory authority inspections Review audit findings, deviations, and CAPAs Partner with Clinical Operations and study teams to ensure GCP compliance Provide quality guidance and identify compliance risks and improvement opportunities What We're Looking For At 10 years of GCP Quality Assurance experience in biotech, pharma, or clinical research within Managerial or Senior Auditor Capacity with evidence of increasing responsibility. Hands-on experience conducting investigator site, CRO, and vendor audits Strong knowledge of ICH E6(R3), FDA GCP regulations, and global clinical compliance requirements Experience supporting inspection readiness and regulatory inspections Strong communication, audit, and stakeholder management skills Preferred Oncology or biotech clinical trial experience Experience with risk-based quality management and vendor oversight

Pay:

$80.00 - $95.00 per hour Application Question(s): Have you independently planned, conducted, and reported GCP audits of investigator sites, CROs, and/or clinical vendors within a biotech, pharmaceutical, or clinical research organization? How many years of dedicated sponsor-side GCP Quality Assurance experience do you have supporting clinical trials? Which regulatory standards have you applied directly while supporting clinical trials for eg: ICH E6(R2/R3), FDA GCP regulations, and EMA guidelines?

Location:

Alameda, CA 94502 (Preferred) Ability to

Commute:

Alameda, CA 94502 (Required)

Work Location:

In person