Quality Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and uphold Standard Operating Procedures (SOPs), Work Instructions, and other guidance at both network and site levels.

• Review and modify SOPs and work instructions to ensure they meet regulatory standards and align with network SOPs.

• Assist in the creation and execution of training events at the network and site levels.

• Perform internal study assessments to ensure compliance with ICH-GCP and relevant regulations.

• Generate reports on study review processes, categorize findings based on risk, and suggest corrective measures.

• Collaborate with operations teams to address issues and noncompliance, and implement preventive strategies.

• Engage in quality investigations.

• Support site operations in the formulation, execution, and monitoring of CAPA plans.

• Evaluate and communicate site risks to operations.

• Conduct and report on quality assessments of external sites for M&A due diligence.

• Contribute to the integration of acquired sites into the network.

• Share best practices to ensure site inspection readiness.

• Participate in external audits and provide updates to internal leadership.

• Monitor and assist with required employee training.

• Aid in the creation and delivery of training materials for site personnel.

• Assist site directors in evaluating employee performance against quality benchmarks.

• Engage in continuing education opportunities.

• Willingness to travel up to 30% domestically and/or internationally.

⛳️ Requirements

• A minimum of 5 years of experience in the clinical research industry is required.

• Certification from a professional clinical research organization is preferred.

• A Bachelor’s degree or equivalent is required.

• An Associate’s degree coupled with 5 years of relevant experience will be considered.

• Comprehensive knowledge of current federal and local clinical research regulations and GCP is essential.

• Skills transferable from other cGXP environments are beneficial.

• Must be comfortable with travel up to 30% domestically or internationally, including Canada.

• Exceptional attention to detail is crucial.

• Strong ability to communicate and collaborate effectively with a diverse team of professionals.

• Excellent communication and organizational skills are necessary.

• Ability to follow directions from a supervisor or work independently as needed.

• Proficient in computer skills and the use of MS Office.

• Capable of building rapport with employees and external clients.

🏝️ Benefits

• Equal Opportunity Employer.

• Reasonable accommodations in employment and the application process for individuals with disabilities.

• Opportunities for continuing education to remain current on relevant quality initiatives, regulatory guidance, and industry best practices.