Clinical Quality Operations Manager- FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel FSP has an exciting opportunity for a Clinical Quality Operations Manager ! This is a remote role !

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).
• Collectively and periodically (e.g. quarterly) perform a Therapeutic Area (TA) level review of quality plans and risk mitigation approaches in order to identify any emerging signals or trends and provide relevant feedback to the CQOL and Head of CQO as appropriate within a specific therapy area.
• Ensure comprehensive oversight of all activities delegated to third parties.
  This will include, but not be limited to:

• Facilitating and monitoring CTT oversight of vendors
• Development, review and revision of quality agreements with business partners (i.e. co-development of products with other pharmaceutical companies).
• Ensuring that essential elements of the quality management system are in place for studies conducted in partnership with non-commercial organizations (e.g. NGO, government or academic institutions).

• Facilitate and oversee the responses to audit and inspection observations as appropriate. In addition, the CQOM will work with peers to analyze data across therapy areas in order to identify signals and trends and will then develop and implement appropriate process improvement strategies.
• Develop skillsets, in collaboration with the CQOL, in order to be able to recognize and appropriately respond to new and emerging risks through the use of technology. In particular this will include developing and maintaining a profound understanding of Good Clinical Practice (GCP) with respect to digital data management (i.e. use of novel technology within clinical trials).
• Build and enable effective working relationships with key stakeholders in order to ensure and maintain role clarity and business effectiveness. This will include ongoing partnership with Client QA and acting as the link between Clinical Development, study teams, global business functions and regional study management.
• Contribute to the standardization of Clinical Quality Operations procedures, tools and templates in order to ensure consistency and seamless progression through the study lifecycle

Inspection Preparation and Management:

• 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.
• Maintain appropriate levels of knowledge and skill in order to effectively lead and support GCP inspections, worldwide. Under the guidance of the CQO Lead, the CQOM may be assigned as Point of Contact (POC) for a specific area of regulations (e.g. FDA, EMA, NMPA, etc.). As such, the Clinical Operations Manager (COM) is responsible for monitoring, interpreting and communicating key regulatory developments within CQO.