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. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
In partnership with the Quality Assurance Lead, the Quality Assurance Specialist (QAS) will support the implementation and management of the Quality assurance strategy across multiple studies, and/or countries within a given Therapeutic Area. The QAS will utilize audit and 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).
- Will represent QA as single point of contact and provides QA guidance for studies in a certain TA or in certain countries
- 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, Pharmacovigilance 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 audit substrate for scheduling, as appropriate.
- In collaboration with the QAL, actively contributes to the quality management oversight, in the development of clinical risk assessments and quality oversight initiatives (quality plan, quality agreements)
- 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.
- Leads 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 and TA Head.
- Interfaces and provides day-to-day support to applicable QA functional line to ensure appropriate quality oversight of assigned studies.
- Participates in the development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency globally.
- Provide inspection management support as appropriate
- Conducts wide range of GxP (Good Practices Quality Guidelines and Regulations) complex audits, (i.e directed, for-cause) in accordance with QA risk-based processes.
- 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.
- Conducts QA audits, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders (e.g. GCTO), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
- Audit preparation and notification to key stakeholders (e.g. review of audit and inspection history, SOPs and relevant quality indicators)
- Conducts Good Clinical Practice (GCP) audits of clinical investigator sites and COs.
- Conducts GCP audits of regulatory documents and marketing applications.
- Conducts PV (Pharmacovigilance) related audits at sites/country organizations, and vendors.
- Conducts risk assessments of licensing, third party collaborations and/or acquisition products/compounds.
- Conducts audits of vendors (e.g. CROs (Contract Research Organizations), Phase 1 facilities, etc.)
- Conducts for-cause, directed audits and complex audits
- Develops and delivers awareness sessions with minimal supervision on various GCP and PV topics internally and externally.
- Acts as a strong technical resource and is called upon to resolve GCP/PV issues based on knowledge of relevant SOPs (Standard Operating Procedures), GCP, PV regulations and guidelines as well as local regulations.
- Promotes standardization of auditing approach within QA.
- Routinely suggests new audit techniques/aids in areas of technical expertise
- Design and actively participate 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.
- Requires up to 40% time for conducting audits (including travel) and attending QA meetings.
- Ensures the work climate/culture within QA, exemplifies the Merck Leadership behaviors.
- Bachelor's degree or equivalent
- 8 or more years of relevant pharmaceutical experience (i.e., drug development, clinical and/or non- clinical research, regulatory compliance, clinical study monitoring or Pharmacovigilance)
- A minimum of including at least 3 years previous clinical Quality Assurance experience conducting a broad range of audits.
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