Quality Assurance Specialist

Responsible for providing senior support in planning, organizing and/or evaluating the day-to-day delivery of global quality assurance (QA) services. Responsible for supporting the business in quality assurance, policy planning and development, ongoing quality improvement through clinical audit and liaison with other business units and external partners. Will also provide support, expertise, and industry best practice guidance.

Quality Assurance Implementation:
• Implement quality assurance plans and processes and identify indicators needed to assess product/service quality levels.
• Collaborating with management/functional experts or Sponsors to identify requirements of the organization in order to conduct internal audits, site audits, vendor assessments and vendor audits.
• Oversee the development of Quality System documents including policy, procedure, instruction, guidance and form and template development in collaboration with departments and senior management.
• Develop QA processes, train and oversee junior QA staff.
• Liaise with the Human Resources department to ensure that all staff are qualified.
• Remain current on and ensure internal awareness of regulatory trial conduct standards and requirements.
• Identify changes to standards and regulations governing Clinical Research and provide recommendations for implementation as required.

Regulatory, Ethical Conduct and Audit Monitoring :
• Remain current on, interpret and communicate changes to regulatory trial conduct standards and requirements.
• Identify, implement and/or develop policies, processes, and/or training to meet these standards.
• Plan/lead/facilitate Sponsor and regulatory inspections and audit activities including preparation of staff, oversight of proceedings and ensure findings addressed are resolved.
• Perform internal audits and vendor assessments, ensuring that all observations are appropriately addressed and resolved.
• Communicate audit findings to internal stakeholders and provide guidance to teams regarding the development of Root Cause Analysis and Corrective Preventive Actions.
• Liaise with other departments in the completion of Sponsor requests for information.
• Support internal departments with privacy related questions or inquiries

Product/Service Consulting:
• Provide guidance during product/service enhancements cycles or during times of organizational change around quality compliance and cross-functional process requirements and organization efficiency gains.

Qualifications:
• The successful candidate will possess either an undergraduate degree with 4-6 years of related experience and on the go training, or a College Diploma with 7-9 years of related experience and training.
• Life Sciences, Clinical Research, Information Technology or Clinical Quality Assurance specialty preferred. Strong analytical, critical thinking and problem-solving skills required. Knowledge of ICH GCP, global regulations governing Clinical Research and global privacy regulations.