Clinical Quality Assurance Professional

This role will globally assess processes and procedures, operations, and compliance to Good Clinical Practice (GCP) regulatory requirements/standards and controlled documents.

Responsibilities:

• Participate in problem-solving with Clinical Leadership, Clinical Study teams, and Clinical Functional teams
• Participate in setting up and maintaining quality systems that are compliant with applicable clinical regulations and standards; this includes assisting in the assessment, creation, and presentation of quality metrics within Clinical
• Support the Clinical vendor qualification, selection, and management process
• Plan, schedule, and conduct or oversee internal and external quality assurance audits of the systems, procedures, and controls employed in the design, conduct, and analyses of clinical trials; document/review audit observations and responses; evaluate impact and make recommendations for improvement initiatives
• Provide compliance guidance and leadership for regulated activities including the preparation and coordination of inspections/audits by regulatory authorities for clinical trials; provide inspection readiness training for Clinical Study teams
• Assess compliance of Sponsor/Investigator/Monitor/Vendor to the protocol, ICH GCP (International Conference on Harmonization Good Clinical Practice) guidelines and all applicable regulations; this includes the documentation/data that is generated, documented, and reported
• Maintain knowledge of industry and regulatory trends as required to meet business needs and perform the responsibilities of the position; advise leadership on the possible ramifications of regulatory changes
• Provide systems compliance oversight of computer systems implemented to support clinical activities; participate in development of quality management system documentation related to computer systems/software use
• Provide compliance guidance and advice to Clinical Study teams and functional groups
• Participate in the assessment of Clinical Vendor systems compliance supporting clinical activities

Required Qualifications:

• Ability to travel up to 25%, as necessary, to achieve business and project objectives
• Working knowledge of inspection management
• Knowledge of the clinical research lifecycle and Subject Data Protection regulations and laws
• Demonstrated project management and leadership skills
• Knowledge of Good Clinical Practices (GCP) and all applicable regulations
• Bachelor's degree
• Minimum of 3 years experience in the Biotech, Medical Device, Pharmaceutical or Healthcare industries
• Strong verbal and written communication skills
• Minimum of 2 years experience in clinical and/or quality system compliance and auditing
• Organizational skills, flexibility, and ability to multi-task

Desired Qualifications:

• Travel%: 25%
• Knowledge in 21CFR Part 11 and application of predicate rules with respect to clinical processes and systems