Clinical Quality Operations Manager, Oncology

Merck • North Wales, PA

9d • $142,400 - $224,100 • Remote

About The Position

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. The Clinical Quality Operations Manager (CQOM) is accountable for the execution of operational quality activities within the assigned therapeutic area, including operational quality management and inspection management. The CQOM 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 incumbent will be accountable for the development of quality plans to implement 'quality by design' within clinical development programs, using a risk-based approach. The incumbent will be accountable for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections.

Requirements

• 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, 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.
• 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 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.
• Adaptability
• Clinical Quality Management
• Clinical Study Design
• Clinical Trial Planning
• Clinical Trials Monitoring
• Data Analysis
• ICH GCP Guidelines
• Medical Writing
• Process Improvements
• Regulatory Compliance
• Risk Management
• Strategic Planning
• Strategic Thinking
• Team Leadership
• Training and Development

Nice To Haves

• Further formal education in quality management or business management is preferred.
• Current Employees apply HERE
• Current Contingent Workers apply HERE
• US and Puerto Rico Residents Only
• San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
• Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Responsibilities

• 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 Clinical Trial Team (CTT).
• Periodically perform a therapeutic area (TA)-level review of quality plans and risk mitigation approaches to identify emerging signals or trends and provide feedback.
• Facilitate and oversee responses to audit and inspection observations.
• Analyze data across therapy areas to identify signals and trends and develop/implement process improvement strategies.
• Develop skillsets to recognize and respond to new and emerging risks through technology, with a focus on Good Clinical Practice (GCP) and digital data management.
• Build and enable effective working relationships with key stakeholders, including research division QA, Clinical Development, study teams, global business functions, and regional study management.
• Contribute to the standardization of Clinical Quality Operations procedures, tools, and templates.
• Ensure comprehensive oversight of all activities delegated to third parties, including facilitating and monitoring CTT oversight of vendors.
• Develop, review, and revise quality agreements with business partners.
• Ensure essential elements of the quality management system are in place for studies conducted with non-commercial organizations.
• Maintain current regulatory inspection knowledge related to GCP inspections by global regulatory agencies.
• Effectively lead and support GCP inspections worldwide.
• Monitor, interpret, and communicate key regulatory developments.
• Provide comprehensive oversight of the TA in collaboration with other therapeutically aligned CQOMs.
• Maintain awareness of filing schedules, potential future inspections, and ongoing inspection preparation activity.
• Develop, update, and maintain GCP inspection procedures and guidelines.
• Contribute to the development and/or revision of Company policies, SOPs, and training materials.
• Develop the strategy for management/support for GCP inspections of Company products to ensure consistent, professional, and proactive handling of all phases of Regulatory Health Authority inspections.
• Ensure a cross-functional team is informed and prepared to support any Regulatory Health Authority inspection.
• Maintain and QC the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses, and CAPAs.
• Act as the subject matter expert and primary point of contact for relevant functional areas on Inspection Management.
• Escalate potentially significant inspection findings/compliance risks/impact to Company Senior Management.
• Develop the inspection management plan for each assigned and identified Regulatory Health Authority inspection.
• Ensure all actions and commitments related to audits and inspections are implemented in a timely manner.
• Track all inspection CAPA and regulatory commitments and check evidence of completion.
• Ensure a repository of evidence is complete for all Regulatory Health Authority inspections.
• Provide guidance and support for CCQMs regarding inspections at country-level sites requiring Company headquarters input.
• Provide input into GCP Quality and Compliance Council regarding the QMS, RACT, Quality Plans, and Regulatory Health Authority inspections status and results.
• Assess and provide input to strengthen company programs/strategies to increase Inspection Readiness.
• Lead, drive, facilitate, and/or support remediation, prevention activities, process improvement, and training as needed.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Associate degree