R D GCP Quality Assurance Sr. Specialist / 非公開
|職種||R D GCP Quality Assurance Sr. Specialist|
Basic Functions Responsibilities:
In partnership with the Quality Assurance Lead （QAL） the Quality Assurance Specialist （QAS） will support the implementation of the quality assurance strategy across multiple clinical studies and/or countries in Asia Pacific including Japan.
The QAS position is responsible for the execution of the global Quality Assurance （QA） audit activities on assigned clinical studies/suppliers including laboratories/Country Offices （CO） in the region. This role is responsible for GCP oversight and for assuring the compliance of clinical studies with 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 relevant business stakeholders （e.g. clinical trial team） 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 related routine and directed audits of investigator sites country offices suppliers including laboratories regulatory documents and marketing applications and due diligence activities.
・Demonstrates and understanding of PV practices is preferred.
・Participates in the development/enhancement of QA procedures guidance documents and audit tools to ensure QA consistency globally.
・Promotes standardization of auditing approach within QA.
・May represent QA as a single point of contact and provide QA guidance for clinical studies in a certain Therapeutic Area （TA） or in certain countries to achieve continuous quality improvement and effective quality assurance.
・Interfaces with relevant stakeholders including regulatory clinical and development sub teams as appropriate to provide Good Clinical Practice QA expertise.
・Contributes to the QA strategy and supports QA goals for the aligned studies/countries in the 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 scheduli
Primary skills include but are not limited to:
・Clinical/Regulatory Expertise: Broad and in depth knowledge of the drug development process GLP GCP and GVP 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 in English.
・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.
・Influencing: Ability to influence and negotiate with key stakeholders. Decision Making: Demonstrates good judgment and decision making.
・Time Management: Ability to multi task and manage time efficiently and effectively.
・Cultural Agility: Demonstrates ability to work in a culturally diverse environment.
BS/BA degree in relevant area with significant experience in field and experience in the pharmaceutical industry including experience conducting a broad range of audits.
|年収||700万円 - 1500万円|