Senior / Project Quality Assurance Lead - US/Canada - Remote
About The Position
The Quality Assurance department at Worldwide Clinical Trials sets a high standard for quality, aiming to exceed the requirements of sponsors, study participants, and regulatory authorities. Our QA culture fosters an environment where staff are trained, energized, and empowered to deliver high-quality products to both employees and customers. This role involves collaborating with project teams to ensure compliance with study protocols and regulations, acting as a GCP Subject Matter Expert, managing quality issues, participating in risk management, performing quality assurance reviews, and supporting site inspections and audits.
Requirements
- Professional, concise, clear, and consistent communication and approach for internal and external customers.
- 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.
- 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.
Nice To Haves
- Experience in supporting Regulatory Inspections is preferred.
- GxP (e.g., GLP, GMP, GPVP, GPP) knowledge in addition to advanced GCP knowledge preferred.
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) including development of Corrective and Preventive Action (CAPA) Plans for assigned projects.
- Participate in risk management activities.
- Proactive identification of 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.
Benefits
- Competitive benefits package depending on location.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
