Clinical Quality Operations Manager - Remote

Clinical Quality Operations Manager

In partnership with the Clinical Quality Operations Lead and Head of Clinical Quality Operations, the Clinical Quality Operations Manager is accountable for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The Clinical Quality Operations Manager will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed quality into our company's sponsored trials, ensure adequate vendor oversight and address any quality issues as needed.

The Clinical Quality Operations Manager will be accountable for the development of quality plans to implement quality by design within clinical development programs, using a risk-based approach. The Clinical Quality Operations Manager will be accountable for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, managing and following up of regulatory inspections.

Responsibilities include:

Operational Quality Management:

• Overseeing the strategic implementation of quality by design principles in assigned clinical trials.
• Developing Risk Assessment and Categorization Tools and Quality Plans in partnership with the Clinical Trial Team.
• Performing a TA-level review of quality plans and risk mitigation approaches in order to identify any emerging signals or trends.
• Facilitating and overseeing the responses to audit and inspection observations.
• Developing and maintaining a profound knowledge of Good Clinical Practice with respect to digital data management.
• Building and enabling effective working relationships with key stakeholders.
• Contributing to the standardization of Clinical Quality Operations procedures, tools and templates.
• Ensuring comprehensive oversight of all activities delegated to third parties.

Inspection Preparation and Management:

• Maintaining current regulatory inspection knowledge as it relates to Good Clinical Practice.
• Working with other therapeutically aligned Clinical Quality Operations Managers to provide comprehensive oversight of the TA.
• Developing, updating, and maintaining GCP inspection procedures and guidelines.
• Contributing to the development and/or revision of Company policies, SOPs and training materials.
• Ensuring that a cross-functional team is fully informed and prepared to support any Regulatory Health Authority inspection.
• Maintaining and QC the global inspection tracking system.
• Acting as the subject matter expert and primary point of contact for relevant functional areas on inspection management.
• Escalating potentially significant inspection findings/compliance risks/impact to Company Senior Management.
• Developing the inspection management plan for each assigned and identified Regulatory Health Authority inspection.

CAPA Management Support:

• Ensuring that all actions and commitments related to audits and inspections are implemented in a timely manner.
• Ensuring repository of evidence in Documentum is complete for all Regulatory Health Authority inspections.
• Providing guidance and support for Clinical Quality Operations Managers regarding inspections at a country level sites.

Other activities:

• Providing input into GCP Quality and Compliance Council.
• Assessing and providing input to strengthen company programs/strategies.
• Leading, driving, facilitating and/or supporting remediation, prevention activities as process improvement and training.

Education:

B.A./B.S. or M.A./M.S. Degree or equivalent in relevant health care area. Further formal education in quality management or business management is preferred.

Prerequisites:

• Minimum of 6 years in clinical research including at least 2 years with developing and managing clinical quality systems and management of regulatory inspections.
• Profound knowledge and comprehension of clinical development programs, clinical trial processes as well as quality management systems and quality control tools.
• Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.
• Has delivered effective CAPA management solutions.
• Has worked with risk management tools and processes within the clinical quality framework.

Skills:

• Superior oral and written communication skills in an international environment.
• Ability to manage and develop others, including formal performance management when necessary.
• Excellent project management and organizational skills.
• Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
• Ability to lead cross-functional teams of business professionals within and outside our Research division.
• Able to act urgently for worldwide health authority inspection matters.
• Ability to analyze, interpret and solve complex problems.
• Ability to think strategically and objectively and with creativity and innovation.
• Ability to proficiently interact with all levels of specialists & management and exert influence to achieve results.
• Ability to identify and summarize the key issues from audits and inspections and to develop and deliver lessons learned.