Clinical Quality Manager

This role is for upcoming future opportunities that may arise at Fortrea.

Preference for East Coast time zone.

Job Overview:

As the Clinical Quality Manager, you are responsible for the execution of operational quality activities within the assigned therapeutic area. 

This includes operational quality management and inspection management activities. The CQM will oversee clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed quality into sponsored trials, ensure adequate vendor oversight and address any quality issues as needed. The incumbent will be responsible for the overall strategy for maintaining ongoing inspection readiness as well as preparing for management and follow-up of regulatory inspections.

Summary of Responsibilities:

On the Client level:

• ICH Guidance and GCP Regulations, Country Client SOPs: Is an expert at local level.
• Responsible for overseeing the strategic implementation of `quality by design` principles in assigned clinical trials. 
• The CQM will be the single point of contact for clinical trial teams for all activities associated with risk-based quality management (RBQM).  E.g. risk assessment and categorization, risk responses and analyses and critical to quality factors.
• The CQMs within a specific therapy area will collectively and periodically (e.g. quarterly) perform a TA-level review of quality plans and risk mitigation approaches to identify any emerging signals or trends and provide relevant feedback to the CQOL and Head of CQO as appropriate.
• The CQM is responsible for ensuring 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).
• The CQM will facilitate and oversee the responses to audit and inspection observations as appropriate.  In addition, the CQM 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. 

Inspection Prep and Management:

• The CQM is responsible for maintaining 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.
• The CQM is responsible for maintaining appropriate levels of knowledge and skill in order to effectively lead and support GCP inspections, worldwide.  Under the guidance of the CQO Lead, the CQM may be assigned as Point of Contact (POC) for a specific area of regulations (e.g. FDA, EMA, NMPA, etc.). As such, the COM is responsible for monitoring, interpreting and communicating key regulatory developments within CQO.
• Collaborate with other therapeutically aligned CQM to provide comprehensive oversight of the TA. Maintain contemporaneous awareness of filing schedules, potential future inspections and ongoing inspection preparation activity.
• Develops, updates, and maintains GCP inspection procedures and guidelines within GCTO.

CAPA Management Support:

• Ensures 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.
• Ensures repository of evidence in Documentum (containing evidence of CAPA and commitment completion, as well as other definitive inspection documentation) is complete for all Regulatory Health Authority inspections.
• Provides guidance and support for CCQMs regarding inspections at a country level sites

Qualifications (Minimum Required):

• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.
• Expert knowledge of ICH Guidelines and GCP including understanding of regulatory requirements in other countries.
• Expert knowledge and understanding of the drug development process.
• Fluent in local office language and in English, both written and verbal.

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