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Job Description

It is business critical that our Company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. In collaboration with the Clinical Quality Operations Lead {CQOL and Head of Clinical Quality Operations (HCQO), the Clinical Quality Operations Manager (CQOM)} is responsible 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 sponsored trials, ensure adequate vendor oversight and address any quality issues as needed. The incumbent will be responsible for the development of quality plans to implement quality by design within clinical development programs, using a risk-based approach. The incumbent will be responsible for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections.

Primary Responsibilities:

Operational Quality Management

• Develop Risk Assessment and Categorization Tools and Quality Plans in partnership with the Clinical Trial Team (CTT).

• Collectively and periodically (e.g. quarterly) perform a Therapeutic Area (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.

• Responsible for ensuring comprehensive oversight of all activities delegated to third parties. This will include, but not be limited to: 1) Facilitating and monitoring CTT oversight of vendors; 2) Development, review and revision of quality agreements with business partners (i.e. co-development of products with other pharmaceutical companies); and 3) Ensuring that essential elements of the quality management system are in place for studies conducted in partnership with non-commercial organizations (e.g. Non-Governmental Organization (NGO), government or academic institutions).

• 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 collaboration with the CQOL, the CQOM will develop skill sets 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 understanding of Good Clinical Practice (GCP) with respect to digital data management (i.e. use of novel technology within clinical trials).

• 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 the Research & Development Division Quality Assurance (QA) and acting as the link between Clinical Development, study teams, global business functions and regional study management.

• In collaboration 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.

Inspection Preparation and Management

• Responsible for maintaining current regulatory inspection knowledge as it relates to GCP inspections by regulatory agencies worldwide, especially those conducted by key authorities such as the United States of America Food and Drug Administration (FDA), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency, as well as other established and emerging authorities.

• 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 (POC) for a specific area of regulations (e.g. FDA, EMA, NMPA, etc.). As such, the CQOM is responsible for monitoring, interpreting and communicating key regulatory developments within CQO.

• Collaborate 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 Global Clinical Trial Operations (GCTO).

• Contributes to the development and/ or revision of our Company policies, SOPs and training materials.

• Develops the strategy for management/support for GCP inspections of our 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 commitment to regulatory compliance.

• Ensures that a cross-functional team (e.g. Quality & Continuous Improvement (QCI) colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (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 Corrective Action and Preventive Action (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 our 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 headquarters input.

Other Responsibilities

• Provides input into GCP Quality and Compliance Council regarding the Quality Management System (QMS), Risk Assessment Categorization Tool (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. Quality Control Visit (QCV), Headquarters Quality Control Protocol (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:

• Bachelor’s or equivalent in relevant health care area. Further formal education in quality management or business management is desirable.

• Master's degree preferred.

Required Experience and Skills:

• Minimum of 6 years of relevant experience in clinical research, including at least 2 years of direct experience with developing and managing clinical quality systems and management of regulatory inspections.

• Knowledge and understanding of clinical development programs, clinical trial processes as well as quality management systems and quality control tools is required.

• Expert knowledge of International Council for Harmonization Good Clinical Practice (ICH-GCP) and worldwide Regulatory Health Authority requirements.

• Experience with delivering effective CAPA management solutions.

• Experience with risk management tools and processes within the clinical quality framework.

• Superior oral and written communication skills in an international environment.

• Manage and develop others, including formal performance management when required.

• Excellent project management and organizational skills.

• Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.

• Lead cross-functional teams of business professionals within and outside the Research & Development Division.

• Act urgently for worldwide health authority inspection matters.

• Analyze, interpret and solve complex problems.

• Think strategically and objectively and with creativity and innovation.

• Proficiently interact with all levels of specialists & management and exert influence to achieve results.

• Identify and summarize the key issues from audits and inspections and to develop and deliver lessons learned.

ResearchDivisionGCTO

#EligibleforERP

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

$135,500.00 - $213,400.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .

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):

n/a

Job Posting End Date:

11/7/2024

*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: R318562