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 partnership with the Therapeutic area (TA) Quality Assurance Lead (QAL, Director QA), the Quality Assurance Specialist (QAS) will support the implementation and management of the Quality assurance strategy across multiple studies. The QAS will conduct audits and utilize audit/inspection intelligence and risk mitigation plans to assure adherence to GCP in conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients.
The QAS position is responsible for the execution of the global Quality Assurance (QA) audit activities on assigned studies/products/vendors/Country Offices (CO). This role is responsible for Good Clinical Practice (GCP) and/or Pharmacovigilance (PV) oversight, and for assuring the compliance of studies with Merck Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US FDA, EU Directives, ICH, and National regulations).
* Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders (e.g. Clinical Operations), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable. * Activities may include routine and directed audits of investigator sites, country offices, vendors, regulatory documents and marketing applications, third party collaborations and due diligence activities. * Will represent QA as single point of contact and provides QA guidance for studies in a certain TA. * Serves as member of project team with participation in the applicable forums, providing GCP compliance advice and guidance to customers, to achieve continuous quality improvement and effective quality controls. * Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide Good Clinical Practice, and QA expertise. * Contributes to the QA strategy and support s QA goals for the aligned studies/countries in a given TA/Region * Proactively identifies analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk based QA assessments and to support the implementation of associated risk mitigation strategies * In alignment with risk assessments, supports the identification of audit substrate for scheduling, as appropriate. * Be able to analyze and leverage quality indicators and data to identify potential trends and risks, and perform root cause analyses to enable principles of knowledge based auditing within respective TA and/or region. * Supports Significant Quality Issues management for aligned studies, including assessment of potential root causes and remediation (corrective and preventative actions) * Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL. * Participates in the development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency globally. * Provides inspection management support as appropriate. * Assesses compliance of clinical investigator 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 working knowledge of Quality Assurance, regulations and auditing. * Develops and delivers awareness sessions with minimal supervision on various GCP topics internally and externally. * Promotes standardization of auditing approach within QA. * Routinely suggests new audit techniques/aids in areas of technical expertise * Designs and actively participates in special assignments on various project teams and work streams as determined by QA management. * Provides training and mentorship to less experienced members of QA staff. * Ensures the work climate/culture within QA, exemplifies the Merck Leadership behaviors.
Training & Education Preferred:
* Bachelor's degree or Nursing degree or equivalent preferred.
Prior Experience Preferred:
* 10 or more years of relevant pharmaceutical experience i.e., clinical research clinical study monitoring, or clinical quality oversight) including at least 3 years previous clinical Quality Assurance experience conducting a broad range of audits.
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