Merck · 23 hours ago
Clinical Quality Operations Manager - Remote
United States
Full-time
Remote
Senior Level
$142K/yr - $224K/yr
6+ years expMerck is a leading healthcare company, and they are seeking a Clinical Quality Operations Manager to oversee operational quality activities within assigned therapeutic areas. The role involves ensuring quality management in clinical trials, maintaining inspection readiness, and developing quality plans using a risk-based approach.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
The Clinical Quality Operations Manager is accountable for overseeing the strategic implementation of `quality by design` principles in assigned clinical trials
The CQOM will develop Risk Assessment and Categorization Tools and Quality Plans in partnership with the CTT
The CQOMs within a specific therapy area will collectively and periodically (e.g. quarterly) perform a 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
The CQOM will 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
In partnership with the CQOL, the CQOM will develop skillsets 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 knowledge of Good Clinical Practice with respect to digital data management (i.e. use of novel technology within clinical trials)
The CQOM will 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 our research division QA and acting as the link between Clinical Development, study teams, global business functions and regional study management
The CQOM, in partnership with peers, will contribute to the standardization of Clinical Quality Operations procedures, tools and templates in order to ensure consistency and seamless progression through the study lifecycle
The CQOM is accountable for ensuring comprehensive oversight of all activities delegated to third parties
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 CQOM 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 CQOM 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 CQOM may be assigned as Point of Contact 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
Work with other therapeutically aligned CQOM 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
Contributes to the development and/ or revision of Company policies, SOPs and training materials
Develops the strategy for management/support for GCP inspections of Company products to ensure that all phases of Regulatory Health Authority inspections (i.e. inspection preparation, management and follow up) are handled consistently, professionally and proactively and result in outcomes that demonstrate the Company’s dedication to regulatory compliance
Ensures that a cross-functional team (e.g. Quality & Continuous Improvement (QCI) colleagues, GCTO Country Operations, other GCTO functional areas, PV, GRACS, IT, etc.) is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide
In collaboration with the Global Inspection Coordinator and Head of CQO, maintain and QC the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses and CAPAs, worldwide
Acts as the subject matter expert and primary point of contact for relevant functional areas on Inspection Management in order to provide real-time, proactive advice and guidance
Escalates potentially significant inspection findings/compliance risks/impact to Company Senior Management
Develops the inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team
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 that require a Company headquarters input
Provides input into GCP Quality and Compliance Council regarding the QMS, RACT, Quality Plans and Regulatory Health Authority inspections status and results, including escalation of overdue CAPA commitments
Assesses and provides input to strengthen company programs/strategies (e.g. QCV, HQ QCP) with an aim to increase Inspection Readiness
Leads, drives, facilitates and/or supports remediation, prevention activities as process improvement and training, as needed
Qualification
Required
B.A./B.S. or M.A./M.S. Degree or equivalent in relevant health care area
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
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
Accountability
Adaptability
Clinical Development
Clinical Quality Management
Clinical Research
Clinical Study Design
Clinical Trial Planning
Clinical Trials
Clinical Trials Monitoring
Conflict Resolution
Data Analysis
ICH GCP Guidelines
Inspection Readiness
Leadership
Management Process
Medical Writing
Mergers and Acquisitions (M&A)
Operations Support
Pharmaceutical Management
Process Improvements
Regulatory Compliance
Regulatory Inspections
Risk Assessments
Risk Consulting
Preferred
Further formal education in quality management or business management is preferred
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
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
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2026-01-22
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