[Hiring] Clinical Quality Operations Manager @Merck

Role Description

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

Overarching Tasks:

• Accountable for the execution of operational quality activities within the assigned therapeutic area.
• Oversee headquarters clinical quality operations and support clinical trial teams.
• Proactively embed quality into our Company's sponsored trials.
• Ensure adequate vendor oversight and address quality issues as needed.
• Develop quality plans to implement 'quality by design' within clinical development programs.
• Maintain ongoing inspection readiness and manage regulatory inspections.

Operational Quality Management:

• Oversee the strategic implementation of 'quality by design' principles in assigned clinical trials.
• Develop Risk Assessment and Categorization Tools and Quality Plans in partnership with the CTT.
• Perform TA-level review of quality plans and risk mitigation approaches.
• Facilitate and oversee responses to audit and inspection observations.
• Analyze data across therapy areas to identify signals and trends.
• Develop skillsets to recognize and respond to new and emerging risks using technology.
• Build effective working relationships with key stakeholders.
• Contribute to the standardization of Clinical Quality Operations procedures, tools, and templates.
• Ensure comprehensive oversight of all activities delegated to third parties.

Inspection Preparation and Management:

• Maintain current regulatory inspection knowledge related to GCP inspections.
• Lead and support GCP inspections worldwide.
• Develop and maintain GCP inspection procedures and guidelines.
• Ensure cross-functional teams are informed and prepared for inspections.
• Act as the subject matter expert for Inspection Management.
• Develop inspection management plans for assigned Regulatory Health Authority inspections.

CAPA Management Support:

• Ensure timely implementation of actions related to audits and inspections.
• Track all inspection CAPA and regulatory commitments.
• Provide guidance for inspections at country-level sites.

Other activities:

• Provide input into GCP Quality and Compliance Council.
• Assess and provide input to strengthen company programs/strategies.
• Lead and support remediation and process improvement activities.

Qualifications

• 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.

Requirements

• Minimum of 6 years in clinical research including at least 2 years with developing and managing clinical quality systems.
• Profound knowledge of clinical development programs and quality management systems.
• Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.
• Experience in delivering effective CAPA management solutions.
• Experience with risk management tools and processes within the clinical quality framework.

Benefits

• Comprehensive package of benefits including medical, dental, vision healthcare.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.