【1100～1600万円】Seninor Manager Quality Assurance APAC R D Qualit…

【求人No NJB2345038】
As the independent second line assurance function for R D our mission in Quality Assurance is to achieve enduring excellence in auditing quality management quality risk assessment and enhance the R D quality mindset for the benefit of our patients.
The job holder is responsible for:
・ Planning leading conducts and reports audit activities for R D GxP risk based audit programs （GCP GVP GRP Lab GCP GLP）
・ Support of GxP inspection activities
・ Management of CAPAs related to audit and/or inspection findings in collaboration with QA colleagues and functions owning the issues.
・ Supporting the management of business relationships with defined stakeholder groups for quality strategic development and quality management activities for these stakeholders.

■Audit
・ Plans leads conducts and reports audits in assigned GxP areas （GCP GVP GRP Lab GCP GLP） such as investigator site and/or project audits
・ Supports lead auditors in the planning conduct and reporting of more complex audits such as Process / System External supplier
・ Works with contract personnel or consultants to prepare conduct and report outsourced audits

■Inspection
・ Supports Quality Assurance team members to manage and prepare for regulatory inspections

■CAPA
・ Assesses need for and assists in development of CAPA plans approves and monitors plans to completion for assigned audits
・ Assists with the continuing follow up of agreed audit CAPA actions from across QA to assist in the monitoring of QA Key Performance Indicators

■General Accountabilities
・ Ensures own tasks are performed to current practices and in accordance with company policies standards SOPs and guidelines
・ Promotes a culture of ethics integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits
・ Communicates effectively with QA colleagues and business stakeholders
・ Maintains knowledge of relevant industry information affecting quality and compliance arena
・ May provide responsive and proactive quality and compliance advice to defined customers.
・ Support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations
・ Travel expected

■Essential
・ Degree level education or equivalent experience in clinical development and quality management
・ Experience in pharmaceuticals or a related industry
・ Excellent analytical written and oral communications skills
・ Fluent in written and spoken English
・ High ethical standards trustworthy operating with absolute discretion
・ Collaborative influencing and interpersonal skills ・ curious to understand business environment
・ Skilled at managing using technology
・ Ability to develop professional networks with stakeholders

■Desirable
・ Audit Experience
・ Supplier qualification
・ Experience of regulatory health authority GxP Inspections