- Senior Specialist, Therapeutic Area (TA) Quality, MRL Quality Assurance (QA)
Essential functions include but are not limited to: in partnership with the Quality Assurance Lead (QAL) and/or a tenured Quality Assurance Specialist, the Quality Assurance Specialist (QAS) will support the implementation 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 Good Clinical Practice (GCP) Regulations in conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of study participants. The QAS position is responsible for the execution of the global Quality Assurance audit activities on assigned studies/products/vendors/Country Offices. This role is responsible for GCP 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).
Primary activities include but are not limited to:
Serves as the QA single point of contact for project teams and provides Good Clinical Practice (GCP) and/or quality advice and guidance for studies in a certain TA or countries.
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 collaboration with the QAL and tenured QAS, actively contributes to the quality management oversight, in the development of clinical risk assessments, quality oversight initiatives (quality plan, quality agreements) and the identification of audit substrate.
Conducts wide range of GCP audits in accordance with QA risk-based processes. This includes an assessment of clinical investigator sites, vendors, study activities, clinical study reports, submission documents, Country Offices (COs) processes and third party collaboration/licensing/acquisition products against ICH (International Conference of Harmonization), applicable government agency regulations/guidelines, as well as our policies, procedures and industry standards.
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. Participates in the assessment of potential root cause and CAPAs associated with Significant Quality Issues, as needed.
Contributes to the QA strategy and supports QA goals for the aligned studies/countries in a given TA/Region.
May assist with the planning of functional group activities to achieve functional area and/or departmental objectives.
Provide inspection management support as appropriate.
- 【年収】650万円 ～ 1100万円