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

What the Quality Assurance Department does at Worldwide

The Quality Assurance department sets the bar high when it comes to quality. We are committed to exceeding the quality standards required by our sponsors, study participants, and regulatory authorities. Our QA culture is based on an environment where staff are trained, energized, and empowered to deliver high-quality products to our employees and customers.

What you will do

• 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) including development of 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 review 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.
• Assist with Sponsor audits and regulatory inspections as assigned.

What you will bring to the role

• Professional, concise, clear, and consistent communication and approach for internal and external customers.
• Serve as a positive QA ambassador during all daily activities and customer interactions.
• Be competent to manage projects/teams of significant scope and complexity with enthusiasm, prioritizing workload with attention to detail while meeting all deliverables and timelines.
• Work independently, take initiative, and have a flexible approach to work assignments and other assigned tasks.
• Work with a sense of urgency and recognize and deliver on time-sensitive deliverables.
• Have strong influencing and negotiation skills.

Your background

• 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%).

Salary

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

The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it is not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.