岗位职责：

Quality and Compliance Oversight:

•Provide QA support closely aligned with business strategy

•Support the global and regional quality annual objective, strategic initiatives to deliver against the local business plan.

•Provide quality oversight and insight to the R&D and Medical Affair (MA) program in the country (e.g. clinical, precision medicine, phase IV, EAP, IIS, and post marketing program), and ensure the adequate and timely escalation of issues/incidents

•Promote proactive quality and implementation of quality at the onset of program design into execution. Support any necessary vendor-relevant issues identified for the assigned program.

•Support the applicable GCP, GCLP, GVP compliance standards/requirements and their implementation

Quality by Design (QbD) and continuous Improvement:

•Support the Quality by Design (QbD) and Continuous Improvement initiatives for RD PV QA and the R&D clinical programs, MA program, and non-project initiatives across the DS CN organization.

•Drive the standardization of best practise and process improvements in R&D and MA through the business partnering

•Lead/support standardization and process improvement initiatives across D&M Quality and in close collaboration with internal and external stakeholders.

•Identify ways to continuously improve quality and compliance with regulations and company standards, policies and procedures through a partnership with internal and external stakeholders.

•Support local SOP activities, including the creation, review and/or signing of deviations as appropriate.

•Ensure adequate and effective lessons learnt from audit, inspection and quality event are shared and delivered to the relevant stakeholders

•Other duties may be assigned.

Regulatory Inspection:

•Provide guidance to DS CN organization on inspection readiness for Health Authority inspections locally

•Lead the inspection management as the IMT lead for the respective R&D clinical programs and MA program as applicable in alignment with regulatory and development strategies.

•Act as QA representative for health authority inspections. May act as point person for local regulation training as applicable.

Quality Management System:

•Provide oversight and maintain the Quality management System (QMS) in partnership with the relevant business functions (R&D and MA) alignment with the QA business strategy.

•Promote the quality culture in DSCN through the quality culture initiatives and collaboration with the relevant stakeholders

CAPA Management:

•Provide leadership and guidance during the development and execution of CAPAs, ensuring timely escalation to line management of critical incidents/issues.

•Ensure adequate CAPAs are defined, implemented, and closed through providing guidance and facilitation of quality event resolution.

Risk-based Quality Oversight:

•Review and identify risks by evaluating Quality Events, audit and inspection outcomes, data interpretation, and deliver the risk areas/process of improvement to our stakeholders via the QMS scheme (i.e. Quality Review Board) across the R&D and MA organization leaders.

•Promote consistent, transparent, and open communication across both internal and external stakeholders for effective risk-based quality oversight.

•Identify quality risk and maintaining the DS quality platform by measuring KPI / KQI

•Champion the implementation of the study/program-specific quality plan per assigned program. Ensure full understanding of business priorities and their applicability for adequate quality oversight. Ensure business objectives are closely aligned with quality deliverables.

•Ensure oversight of ongoing review of risks by evaluating Quality Events (QEs), audit, and inspection outcomes and sharing with the relevant business functions teams within the DS organization.

External Engagement:

•Contribute, help shape the local external regulatory environment through participation in industry wide organizations to assure the needs of the company are proactively established and that innovative approach to solutions are in place.

•Monitor the compliance metrics trends from the local regulators/ industry experts and align develop the local QMS road map to meet changing regulatory and business needs. Lead remediations and risk management to assure the local organization’s quality management system is robust and ensure knowledge transfer and continuous process improvement in collaboration with other QA functions.

•Drive effective relationship with alliance partners, collaborators, vendors, and other key company partners to ensure a culture of compliance at all levels.

资历要求：

Working Experience:

•Minimum 12 years’ experience working in the bio/pharmaceutical industry or drug development R&D related organizations/institutions; with at least 5 years of experience working in GxP quality areas.

•Experience in leading cross functional projects and/or teams in matrix organization.

•Experience in R&D, QMS, GCP/PV Inspections, Audit, Issue and/or Risk Management and Vendor Management is preferred.