MERIT is a global clinical trial endpoint expert specializing in multiple therapeutic areas.
The company values diversity and seeks people with drive, dedication, and creative problem-solving skills.
Offers flexible schedules and remote opportunities.

Manage Quality Assurance and Compliance team.
Monitor workload across projects and ensure appropriate coverage.
Contribute to the development of Quality Assurance training programs and procedures.
Interview and contribute to the hiring process for new Quality Assurance staff.
Set performance standards for Quality Assurance team and ensure employees understand their duties.
Monitor internal contractor performance and adherence to expected outcomes.
Participate in operational and strategic business directives.
Lead and manage client and regulatory audits.
Comply fully with MERIT policies and Standard Operating Procedures (SOPs).
Develop annual internal audit schedule and perform internal audits.
Maintain vendor and contractor qualifications and audits.
Ensure SOP(s) are followed during daily operations, including CAPA, deviations, non-conformances, and other critical activities.
Responsible for the management and maintenance of personnel files, including orientation and training records.
Perform other duties as assigned.

BA or BS degree in health-related, biological science, clinical research, or service-related fields.
Preferred experience in clinical trials or regulated pre-clinical research.
A minimum of 10 years of quality assurance experience in the medical device, pharmaceutical, or GxP industry preferred.
Proficient computer skills.
Ability to lead a team.
Knowledge of clinical trial data management systems is preferred.
Knowledge of GCP and GxP preferred.
Excellent interpersonal and communication skills.
Ability to problem solve, multi-task, and balance priorities.
Must possess managerial decisiveness to prioritize multiple projects.

Quality Assurance and Compliance Manager Full Time

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