Job Description
In partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities.
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.
Operational Quality Management:
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.
This will include, but not be limited to:
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).
Inspection Preparation and Management:
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.
CAPA Management Support:
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.
Other activities:
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.
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.
clinicaltrialjobs
EligibleforERP
Required Skills:
Accountability, 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 {+ 4 more}
Preferred Skills:
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US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
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:
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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 (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is
$142,400.00 - $224,100.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
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
Search Firm Representatives Please Read Carefully
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.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Remote
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
No
Job Posting End Date:
01/29/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R381100
