Clinical Quality Operations Manager- Remote
Merck & Co.
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Job summary
Merck & Co. in Rahway, NJ is seeking a seasoned Clinical Quality Operations Manager to oversee trial quality, risk management, and inspection readiness across global studies. You will partner with CQOL and CQO to embed quality, manage CAPAs, and coordinate sponsor inspections.
You will lead cross-functional teams, apply QA/QMS principles, and drive continuous improvement in regulatory compliance and trial integrity within a fast-paced pharmaceutical environment.
Qualifications
- Minimum of 8 years of relevant experience in the pharmaceutical industry and/or clinical research.
- Robust knowledge of quality management and clinical trial operations.
- Comprehensive knowledge of QMS, ICH GCP guidelines, and worldwide regulatory requirements.
- Advanced experience in RCA, CAPA development/effectiveness, and service provider oversight.
Responsibilities
- Support Trial Teams and drive Quality by Design implementation.
- Act as Process SME for quality processes and regulatory requirements.
- Identify, investigate, escalate, and resolve study-level quality issues.
- Lead Inspection Hypercare Teams to maintain ongoing inspection readiness.
- Coordinate sponsor inspections and pre-inspection visits.
- Prepare inspection communications and manage CAPA root cause analyses.
Skills
Education
Job description
It is critical that consistent, accurate, high-quality data is generated and maintained from clinical trials conducted worldwide. In collaboration with the Clinical Quality Operations Lead (CQOL) and Head of CQO, the CQOM is responsible for the execution of clinical quality oversight activities within an assigned trial. - -This includes proactive quality management, risk-based quality oversight, and clinical trial inspection management activities. The CQOM will provide clinical quality operations support to Trial Teams (TTs) to proactively embed quality into sponsored trials, ensure robust supplier oversight, and address critical quality issues as needed. The incumbent will assist with the overall strategy for maintaining ongoing inspection readiness, as well as preparing for, managing, and following up on regulatory inspections.
- Independently support assigned Trial Teams (TT) and drive implementation of Quality by Design.
- Act as a Process Subject Matter Expert (SME) within Clinical Quality Operations, providing guidance on quality processes, standards, and regulatory requirements to TTs.
- Support identification, investigation, escalation, and resolution of study-level quality issues including Significant Quality Issues (SQIs) and Serious Breaches (SBs).
- Support Trial Teams in assessing trial health and conducting quality reviews, as needed.
- Lead Inspection Hypercare Teams (IHT) with the aim of ensuring that, at all stages, the Trial Team (TT) maintains ongoing inspection readiness.
- Provide oversight for operational management of sponsor inspections (e.g., act as Control Room Lead or Control Room Support).
- Act as Inspection Lead for site inspections.
- Conduct pre-inspection visit (PIV) for impending site inspections.
- Author key inspection communications (e.g., daily summaries, inspection outcomes, and issue escalations).
- Coordinate the inspection response process managing the root cause analysis, Corrective and Preventive Action (CAPA) and associated regulatory commitments to completion, ensuring that key inspection documentation is maintained at all times.
- Support Quality Assurance audits (i.e., Study Level Audits) providing support to TT before, during and after audit, including coordinating root cause analysis for any applicable observations, development of responses, CAPA management and tracking.
- Collaborate with the Clinical Quality Risk Manager (CQRM) to operationalize quality risk management during trial conduct.
- Provide critical insights from study level audits, inspections, and quality issues and support identification of actionable resolution pathways for quality signals that emerge during trial conduct.
- Serve as the primary clinical quality Point of Contact (POC) for assigned key service providers (e.g., tier 1 and tier 2 service providers).
- Responsible for the strategic development and management of service provider clinical quality agreements.
- Support quality-related mergers and acquisitions activities, as required, to ensure comprehensive knowledge transfer, risk management, and inspection readiness.
- Contribute to the ongoing development of CQO infrastructure and process innovation.
- Support and lead special projects and strategic assignments within CQO as assigned by CQOL.
- Proactively identify and apply AI-driven approaches to improve operational efficiency and decision-making within CQO.
- Work with data and analytics to monitor performance and drive continuous improvement.
Bachelor's or Master's Degree or equivalent in a health care or scientific area.
- Minimum of 8 years of relevant experience in the pharmaceutical industry and/or clinical research.
- Robust knowledge of quality management and clinical trial operations.
- Comprehensive knowledge of Quality Management Systems (QMS), ICH GCP guidelines, and worldwide Regulatory Health Authority requirements.
- Advanced experience in independent root cause analysis (RCA), CAPA development and effectiveness management, and service provider quality oversight.
- Superior oral and written communication skills in an international, matrixed environment.
- Excellent project management and organizational skills.
- Ability to lead cross-functional teams of business and clinical professionals.
- Able to act urgently and decisively on worldwide health authority inspection matters.
- Ability to analyze, interpret, and solve complex quality and compliance issues.
- Ability to think strategically and objectively with digital savvy (awareness of AI and machine learning tools).
- CAPA Management, Clinical Quality Management, Communication, Cross-Functional Teamwork, Data Analysis, Good Clinical Practice (GCP), Process Improvements, Project Management, Regulatory Compliance, Regulatory Inspections, Risk Management, Root Cause Identification, Strategic Thinking, Taking Initiative
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement. We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts.
Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.
We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
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.
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Regular
No relocation
No
25%
Remote
1st - Day
No
N/A
10/23/2026
R422523
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