Job Overview
Location
2 Locations
Job Type
Full-time
Category
Product Management
Date Posted
June 23, 2026
Full Job Description
đź“‹ Description
- • Collaborate with project team members to ensure compliance with study protocols and regulatory requirements.
- • Serve as a GCP Subject Matter Expert (SME), providing GCP consultancy to project teams for assigned clinical trials.
- • Manage and facilitate root cause analysis for Quality Issues (QIs), including the development and implementation of Corrective and Preventive Action (CAPA) plans.
- • Participate in risk management activities and proactively identify risks to ensure appropriate mitigations and controls are established.
- • Perform quality assurance reviews and trending analyses for assigned projects to monitor compliance and identify systemic issues.
- • Provide Clinical Investigator Site inspection and audit support as required by sponsors or regulatory authorities.
- • Review QMD deviations and offer GCP guidance to project teams to maintain regulatory compliance.
- • Collaborate with Therapeutic Area Quality Leads within the QMO team and manage QA-to-QA relationships with Sponsor QA counterparts and quality metrics.
- • Assist with Sponsor audits and regulatory inspections, preparing documentation and supporting responses as assigned.
- • Maintain professional, concise, and consistent communication with internal and external stakeholders.
- • Act as a positive QA ambassador in all daily activities and customer interactions.
- • Manage projects and teams of significant scope and complexity with attention to detail, prioritizing workload to meet deadlines.
- • Work independently with initiative, demonstrating flexibility in adapting to changing priorities and assignments.
- • Operate with a sense of urgency, recognizing and delivering on time-sensitive quality deliverables.
- • Apply strong influencing and negotiation skills to resolve quality concerns and align cross-functional teams.
- • Support domestic and international travel up to 15% as required for audits, inspections, or site visits.
🎯 Requirements
- • Bachelor’s degree in biological, physical, health, pharmacy, or related science with 5+ years of relevant GCP experience, or Master’s degree with 3+ years of relevant GCP experience.
- • Excellent working knowledge of Quality Management Systems, ICH Guidelines, FDA CFR, European Directives and Regulations, and UK Statutory Instruments related to GCP.
- • Demonstrated experience supporting Regulatory Inspections.
- • Strong understanding of drug development processes.
- • GxP knowledge (e.g., GLP, GMP, GPVP, GPP) in addition to advanced GCP knowledge is preferred.
- • Experience working within a Clinical Research Organization (CRO) or pharmaceutical company setting.
🏖️ Benefits
- • Competitive annual salary range of $65,500.00 – $130,500.00 based on experience, education, and performance.
- • Comprehensive benefits package tailored to location.
- • Transparent and equitable compensation practices aligned with labor laws.
- • Opportunity to contribute to improving patient lives through high-quality clinical research.
- • Inclusive and supportive workplace culture that values diversity and individual contribution.
- • Potential for domestic and international travel up to 15%.
Skills & Technologies
See exactly how your profile matches this role — strengths, skill gaps, and what to do about them.
About Worldwide Holdings Corporation
Worldwide Holdings Corporation is a diversified global enterprise engaged in the development, manufacturing, and marketing of a wide range of products and services. The company operates across various sectors, including technology, consumer goods, and industrial solutions, with a strong focus on innovation and sustainability. Worldwide Holdings Corporation is committed to delivering high-quality products and exceptional customer service, aiming to foster long-term relationships with its clients and stakeholders. The company's strategic vision involves expanding its global reach, investing in research and development, and adapting to evolving market demands to maintain a competitive edge in the international marketplace. Their mission is to create value through responsible business practices and a dedication to excellence.
Subscribe to the weekly newsletter for similar remote roles and curated hiring updates.
Newsletter
Weekly remote jobs and featured talent.
No spam. Only curated remote roles and product updates. You can unsubscribe anytime.
Similar Opportunities
PermitFlow Inc.
1 month ago
Apply Digital Corporation
1 month ago