Care Access

Senior Manager, Quality Assurance

Care Access

full-time

Posted on:

Origin:  • 🇨🇦 Canada

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Oversee the daily workflow and schedules of the department. Provide coaching and supervision to QA team, training and onboarding new staff, and ensuring team members are performing to standard of their role. Serve as the GCP lead by providing high standard of quality guidance, advice and support on GCP compliance. Manage and maintain databases for the quality systems and provide quarterly reports and quality metrics to Head of Quality Assurance. Prepare reports to track and communicate outcomes of quality assurance activities.
  • Creation and tracking of the internal audit program for clinical research sites, departments, processes and vendors. Oversee and participate in its execution, peer review staff audit reports, ensuring effectiveness and compliance with regulatory requirements, company policies, and procedures. Manage, co/host and participate in preparation and execution of client audits and regulatory authority inspections.
  • Collaborate with other departments and stakeholders to ensure that quality issues are addressed in a timely and effective manner. Coach and train operational staff on quality processes, including but not limited to reporting of quality issues, root cause analysis, CAPA development.
  • Develop and implement policies and procedures for quality assurance activities. Review, and revision of quality assurance SOPs and procedures.
  • Keep up-to-date with the latest regulatory requirements and industry best practice related to clinical research.
  • International travel up to 25% as required by study requirements, staff needs, and company initiatives.

Requirements

  • Excellent working knowledge of medical and research terminology
  • Excellent working knowledge of applicable regulations and good clinical practices (GCP)
  • Attention to detail
  • Ability to communicate and work effectively with a diverse team of professionals
  • Strong Organizational Skills: Able to prioritize, delegate, direct, support and evaluate others work and follow through on assignments
  • Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients, and vendors.
  • Work effectively and collaboratively with other team members to accomplish mutual goals. Bring a positive and supportive attitude to achieving these goals
  • Strong computer skills with demonstrated abilities using clinical trials databases, IXRS systems, delectronic data capture, MS word and excel
  • Ability to balance tasks with competing priorities
  • Demonstrate effective decision making skills
  • Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
  • High level of self-motivation and energy
  • Ability to work independently in a fast-paced environment with minimal supervision
  • A customer/client centric service mentality
  • Bachelor’s Degree or equivalent research experience
  • A minimum of 8 yrs experience in clinical research, with a minimum of 5 yrs of experience in quality assurance within a site management, CRO or Pharma organization or equivalent environment
  • Experience of performing different type of quality audits e.g., investigator site audits, vendor audits, process audits
  • Experience of regulatory inspections e.g. FDA, EMA
  • Experience of sponsor/CRO audit process
  • Direct line management experience will be an asset
  • Care Access is unable to sponsor work visas at this time.