Job description

The Director of Quality Assurance oversees quality assurance functions for the organization including, but not limited to, development and maintenance of quality assurance programs and policies, oversight of inspections and audits, management of the Quality Documents. To ensure productivity per company's goals.

The Director of Quality Assurance will be responsible for:

• Completing the company's required training, including GCP and IATA.
• Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents and study protocols.
• Developing, implementing, and maintaining an internal audit monitoring system and schedule.
• Leading the ongoing development, management, and implementation of written processes for the effective management of clinical trials.
• Leading the reporting of trends and metrics from all clinical activities to aide in effective process improvement and risk control.
• Maintaining Standard Operating Procedures (SOPs) including periodic review and coordination of the initiation/revision of procedures and policies to ensure compliance with new/revised regulations and guidelines 13406 Medical Complex Drive, Suite 53, Tomball, TX 77375 T I 281-517-0550 F I 281-946-8363
• Ensuring quality incidents are investigated, root cause analysis is performed and that CAPA has been implemented and monitored for effectiveness.
• Performing Quality Documents review and approval (e.g. SOPs, guidance documents)
• Partnering with study teams to identify potential changes and opportunities for process improvement
• Educating and mentoring research team with interpretation of regulatory requirements (e.g., GCPs), SOP requirements, and other guidance documents, as applicable.
• Evaluating responses to monitoring and audit reports with the research team; follow-up with applicable stakeholders to ensure resolution.
• Functions within study teams to conduct feasibility assessments, ongoing quality assurance reviews of clinical research studies, with the goal of assessing site readiness and developing site specific education and processes as needed.
• Any other matters as assigned by management.

Qualifications:

• Bachelor's Degree
• Prior experience working for a CRO, SMO, or related clinical research organization
• 3+ years in trial-related quality and compliance

Job Type: Full-time

Pay: $140,000.00 - $160,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

Education:

• Bachelor's (Required)

Experience:

• Clinical trials: 5 years (Preferred)
• Quality assurance: 3 years (Preferred)

Work Location: Remote

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