Clinical Quality Operations Manager- FSP

Clinical Quality Operations Manager

Position Purpose : The Clinical Quality Operations Manager (CQOM), in collaboration with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality Operations (CQO), is responsible for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed quality into Client sponsored trials, ensure adequate vendor oversight and address any quality issues as needed. The CQOM will be responsible for the development of Quality Plans to implement Quality by Design within clinical Development Programs, using a risk-based approach. The CQOM will be responsible for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections.

Primary Duties :

• Operational Quality Management :

Develop Risk Assessment and Categorization Tools (RACT) and Quality Plans in partnership with the Clinical Trial Team (CTT).

Maintain current regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide, especially those conducted by key authorities such as the USA Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, as well as other established and emerging authorities.

Ensure that all actions and commitments related to audits and inspections are implemented in a timely manner. Tracks all inspection CAPA and regulatory commitments and checks evidence of completion.

Skills and Education :

EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.