본사위치 : Kenilworth, NJ, United States.
[Position Overview: Basic Functions & Responsibilities]
In partnership with the Quality Assurance Lead (QAL), the Quality Assurance Specialist (QAS) will support the implementation and management of the Quality assurance strategy across multiple studies, and/or countries. 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 MSD Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US FDA, EU Directives, ICH, and National regulations).
Primary activities include but are not limited to:
· 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 GCP and PV 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 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 of 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 and/or region.
· Support Significant Quality Issues management for assigned 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.
· 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 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.
· Ensures the work climate/culture within QA, exemplifies the Merck Leadership behaviors.
Over 8 years of relevant QA experiences & Fluent English
Candidate from pharmaceutical industry is preferred (Not Must)
· Clinical/Regulatory Expertise: Broad and in-depth knowledge of the drug development process, GCP/PV guidelines, and applicable regulations is essential.
· Business Acumen/Attention to Detail: Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective.
· Applied Therapeutic Area knowledge: Familiarity with existing company systems, policies and procedures and knowledge of multiple therapeutic areas and nonclinical study conduct, including all projects/premier products is desirable.
· Autonomy: Demonstrated ability to work independently
· Logic and analytical skills: Uses rigorous logic and methods to solve difficult problems with effective solutions.
· Communications: Able to communicate complex information and analyses to a variety of scientific and non- scientific audiences in both verbal and written formats.
· Leadership: Act independently to make key timely decisions with limited oversight by management. Strong ability to motivate teams to embed quality by design through the life cycle of the project.
· Creative thinking: Strong ability to operationalize ideas proposed; frequently engages new ideas or ways of doing things and influences creative thinking.
· Teamwork: Strong interpersonal skills with the ability to work effectively in teams.
MSD, known as Merck in the United States and Canada, is a global healthcare company with a rich history of discovery and innovation. Throughout our 125 history, our researchers have helped to find new ways to treat and prevent illness in people and animals around the world. We've done great things in the past. Today, we're doing great things for the future. This is site is intended for audiences outside the United States and Canada.
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