Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
In partnershipwith the Therapeutic area (TA) Quality Assurance Lead (QAL, Director QA), theQuality Assurance Specialist (QAS) will support theimplementation and management of the Quality assurance strategy across multiplestudies. The QAS will conduct auditsand utilize audit/inspection intelligenceand risk mitigation plans to assure adherence to GCP in conduct of clinical trials, the quality and integrity of generated data, and the rights and welfareof subjects/patients.
The QAS position is responsible for the executionof the globalQuality Assurance (QA) audit activities on assignedstudies/products/vendors/Country Offices (CO). This role is responsible for Good Clinical Practice(GCP) and/or Pharmacovigilance (PV) oversight, and for assuringthe compliance of studieswith Merck Standard OperatingProcedures (SOPs), Policies,and all applicable worldwideregulations and guidelines (e.g. US FDA, EU Directives, ICH, and Nationalregulations).
Resources Managed (budgetand FTEs):
- Reports, as applicable, to QAL.
- Partners with other QA functions toassure consistent professional and appropriate QA support across project andaudit needs.
- Internal Interface: Works with allrelevant QA contacts and other internal local and global MRL staff (ClinicalOperations, Regulatory and SafetyS, Translational medicine) and other contactsincluding Medical Affairs, Compliance, Regulatory, Legal and others.
- External Interface: Works withexternal contacts including worldwide regulatory agencies as applicable toinspection activities.
- Prepares, conducts QA audits,generates audit reports, communicates results to the relevant QA management andexternal relevant stakeholders (e.g. Clinical Operations), and interacts withvarious teams to ensure corrective and preventative actions are taken to bringQA observations to closure as applicable.
o Activitiesmay include routine and directed audits of investigator sites, country offices,vendors, regulatory documents and marketing applications, third partycollaborations and due diligence activities.
- Will represent QA as single point ofcontact and provides QA guidance for studies in a certain TA.
- Serves as member of project teamwith participation in the applicable forums, providing GCP compliance adviceand guidance to customers, to achieve continuous quality improvement andeffective quality controls.
- Interfaces with relevantstakeholders, including regulatory, clinical and development sub-teams, asappropriate to provide Good Clinical Practice, and QA expertise.
- Contributes to the QA strategy andsupport s QA goals for the aligned studies/countries in a given TA/Region
- Proactively identifies analyses andleverages quality indicators and data to identify potential trends and risks toaddress and complete risk based QA assessments and to support theimplementation of associated risk mitigation strategies
- In alignment with risk assessments,supports the identification audit substrate for scheduling, as appropriate.
- Be able to analyze and leveragequality indicators and data to identify potential trends and risks, and performroot cause analyses to enable principles of knowledge based auditing withinrespective TA and/or region.
- Support Significant Quality Issues management foraligned studies, including assessment of potential root causes and remediation(corrective and preventative actions)
- Ensures appropriate and timelyescalation of quality issues, including potential misconduct or issues ofsignificant deviation with projects/products, to the QAL.
- Participates in thedevelopment/enhancement of QA procedures, guidance documents and audit tools toensure QA consistency globally.
- Provide inspection managementsupport as appropriate.
- Assesses compliance of clinicalinvestigator sites, vendors, study activities, clinical study reports and submission documents, and Country Offices(COs) processes against ICH (International Conference of Harmonization),applicable government agency regulations/guidelines, as well as Merck policies,procedures and industry standards. The QAS should have a comprehensive workingknowledge of Quality Assurance, regulations and auditing. Develops and deliversawareness sessions with minimal supervision on various GCP topics internallyand externally.
- Promotes standardization of auditingapproach within QA.
- Routinely suggests new audittechniques/aids in areas of technical expertise
- Design and actively participate inspecial assignments on various project teams and work streams as determined byQA management.
- Provides training and mentorship toless experienced members of QA staff.
Ensures the workclimate/culture within QA, exemplifies the Merck Leadership behaviors.
Please note this can be a remote based position sitting anywhere in the US.
Education Minimum Requirement:
BS, Nursing degree preferred
Required Experience and Skills:
Minimum 1 year of experience in Clinical Quality Assurance and auditing.
Preferred Experience and Skills:
Clinical research experience
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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