Senior / Project Quality Assurance Lead - US/Canada - Remote

About the role

The Quality Assurance department at Worldwide Clinical Trials sets the bar high for quality, ensuring compliance with study protocols and regulations. They are committed to delivering high-quality products and services to both employees and customers.

Responsibilities

• Collaborate with project team members to ensure compliance with study protocols and regulations.
• Act as GCP Subject Matter Expert (SME), providing GCP consultancy to project teams for assigned projects.
• Manage and facilitate investigation and root cause analysis for Quality Issues (QIs), developing Corrective and Preventive Action (CAPA) Plans for assigned projects.
• Participate in risk management activities.
• Proactively identify risks to ensure mitigations and controls are in place.
• Perform quality assurance review and trending activities for assigned projects.
• Provide Clinical Investigator Site inspection and audit support as required.
• Provide GCP consultancy and reviews QMD deviations for project teams.
• Collaborate with Therapeutic Area Quality Leads within the QMO team and support with managing the QA-to-QA relationship with Sponsor QA counterparts and quality metrics.
• Aid with Sponsor audits and regulatory inspections as assigned.

Requirements

Professional, concise, clear, and consistent communication and approach for internal and external customers.

Serves as a positive QA ambassador during all daily activities and customer interactions.

Competent to manage projects/teams of significant scope and complexity with enthusiasm, prioritizing workload with attention to detail while meeting all deliverables and timelines.

Works independently, takes initiative and has a flexible approach to work assignments and other assigned tasks.

Works with a sense of urgency and recognizes and delivers on time-sensitive deliverables.

Strong influencing and negotiation skills.

Qualifications

• Bachelor’s degree or equivalent with concentration in biological, physical, health, pharmacy or other related science and 5+ years of relevant GCP experience or 3+ years of relevant GCP with a M.S. or equivalent in a scientific or allied health field preferably within a Clinical Research Organization (CRO) or pharmaceutical company setting.
• Excellent working knowledge of Quality Management Systems, ICH Guidelines, FDA Code of Federal regulations, European Directives and Regulations, and UK Statutory Instruments relevant to GCP.
• Excellent understanding of drug development processes.
• Experience in supporting Regulatory Inspections is preferred.
• GxP (e.g., GLP, GMP, GPVP, GPP) knowledge in addition to advanced GCP knowledge preferred.
• Domestic and international travel may be required (not exceeding 15%).

Skills

• Communication and approach for internal and external customers.
• Project management and team leadership.
• Risk management and mitigation.
• Quality assurance and compliance.
• Regulatory affairs and inspections.
• Drug development processes.

Benefits

At Worldwide Clinical Trials, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws.

Pay

The salary range for this position is annually:

• United States of America - $65,500.00 - $130,500.00

Schedule

Not specified.