Job Information
Merck Country Clinical Quality Manager, US - Remote in Albany, New York
Job Description
It is critical that, for all company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The CCQM position has a significant impact in achieving those objectives.
Under the guidance of the Regional Director, Clinical Quality Management (RCQM), the CCQM oversees all CQM activities in the respective country/cluster.
The role requires the ability to properly implement local/global processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives. In addition, the CCQMs support audits, inspections as well as Quality Control and local training activities.
Qualifications:
- Bachelor's Degree or equivalent in relevant health care area.
Experience:
A minimum of 6 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments. Experience in Country Operations preferred.
Deep knowledge and understanding of Clinical Trial processes, GCP and other clinical research related regulations.
Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
Demonstrated experience in leading cross-functional teams.
Ideally, experience in Clinical Quality Management including Quality Control Activities, Process Management & Improvement.
Ideally, experience in managing audits and inspections.
Ideally, experience in coordinating and delivering training sessions.
Skills:
Superior oral and written communication and leadership skills in an international environment.
Excellent project management, organizational and prioritization skills.
Excellent teamwork skills, including conflict resolution expertise and discretion.
Ability to analyze, interpret, and solve complex problems.
Ability to think strategically, objectively and with creativity and innovation.
Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results.
Regulations & Processes:
Local expert for ICH-GCP and local regulations (incl. impact assessment of new/updated local regulations on local processes).
In close collaboration with local country operations management, manages the local network of owners / Subject Matter Experts (SMEs) for global/local processes to ensure a proper implementation of global/local processes and the regular update of local Standard Operating Procedures (SOPs) / Work Instructions (WIs).
Local expert for any quality-related local processes.
Identifies process gaps / opportunities for process improvement and properly escalates to RCQM and/or Global Process Owners (if necessary).
Leads continuous quality improvements activities at the country level as agreed with Country/Cluster CRD and RCQM and supports or co-leads continuous improvements activities at the global/regional level.
Training:
Local training point of contact and the liaison between local country operations and our Research Division Learning & Development (L&D).
In close cooperation with local country operations management, identifies / coordinates local training needs.
Supports local trainings (as needed).
Quality Control (QC) Activities:
In conjunction with the local country operations management, coordinates and oversees all QC activities. This includes to ensure a proper execution of the In-house Quality Control Plan (IHQCP), the Quality Control Visits (QCVs) as well as any other QC Checks.
In mutual agreement with local country operations management and the RCQM, performs QC activities (incl. QCVs) and conducts ad hoc site visits upon request.
On a regular basis and in collaboration with local country operations, identifies local trends, performs root-cause-analysis (if necessary), develops local action plan (incl. sharing of results and training of local country operations, if required).
Audits & Inspections:
Primary local point of contact for our Research Division Quality Assurance and Regulatory Agencies.
Manages and supports activities during the preparation / ongoing / follow-up phase of an audit or inspection.
In cooperation with local country operations and/or headquarters, performs root-cause-analysis for audit observations/inspection findings, manages and tracks the Corrective and Preventive Actions (CAPAs) and coordinates/facilitates the responses to audit/inspection reports.
On a regular basis and in collaboration with local country operations, identifies local trends, performs root-cause-analysis (if necessary) and develops local action plan (incl. sharing of results and training of local country operations, if required).
Quality / Compliance / Privacy Issue Escalation:
Communicates/escalates quality/compliance issues (incl. any potential trends) to local country operations management and RCQM.
Escalates significant quality/compliance issues and supports investigations (fact finding, root-cause-analysis) as well as the reporting of ‘Serious Breaches’, if applicable.
Serves as local POC or supports local POC in case of escalations/reporting of Privacy Incidents, if applicable.
Clinical Supplies GCP Investigations
Evaluates trends on Clinical Supply GCP Inquiries and incorrect management of clinical supplies.
Coordinates GCP Investigations of trends related to Clinical Supply GCP Inquiries and incorrect management of clinical supplies (if necessary).
Supplier Qualification:
Leads local supplier qualifications and re-qualifications of locally selected suppliers and supports solving of quality issues with locally selected suppliers.
Supports the Quality Management System (QMS) assessment for local supplier qualifications and re-qualifications.
Research Division Compliance & Privacy Steward:
Supports implementation of divisional compliance/privacy initiatives and reporting at the local level.
Communicates compliance/privacy concerns to local legal/compliance/privacy department and/or our Research Division's Compliance/Global Privacy Office.
Global / Regional Key Initiatives / Projects
Supports global/regional key initiatives/projects upon request of the RCQM.
#EligibleforERP
ResearchandDevelopmentGCTO
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
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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:
Yes
Hazardous Material(s):
No
Job Posting End Date:
11/5/2024
*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: R318959