岗位职责：

The associate director reports to Head RDPV QA office (DSCN).

Work in close collaboration with Head RDPV QA office (DSCN) to implement QA missions and strategies regarding Development & Medical QA, including

but not limited to:

•Contribute to the development of RDPV QA strategy in DSCN and facilitate the implementation of the QA strategy within the organization.

•Accountable to drive a proactive approach to quality and responsible for instilling a consistent quality mindset and culture through partnering with the relevant stakeholders to streamline the product lifecycle process and develop the risk mitigation strategies.

•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)

•Support the inspection readiness activities and lead the inspection management activities in DSCN in collaboration with the related functions.

•Responsible for the Quality Event (QE) management, provide guidance during the development and execution of CAPAs and ensure the adequate and

timely escalation of incidents/issues.

•Support the Quality by Design (QbD) and continuous improvements plan for R&D clinical program, MA program, and non-project initiatives across the country organization, review and identify risks by evaluating Quality Events, audit and inspection outcomes, data interpretation, and deliver the risk areas/process of improvement to the relevant stakeholders via the QMS scheme (i.e. Quality Review Board).

•Partner and collaborate with key stakeholders of QA to ensure that key priority programs are adequately supported and that submission relevant

activities are performed.

•Provide guidance to the QA stakeholders in quality and compliance decision making to drive sustainable and proactive quality.

•Identifies areas of continuous process improvement and engages QA teams as necessary as well as key stakeholders. Identify ways to continuously

improve quality and compliance with regulations and company standards, policies and procedures through partnership with stakeholders and QA line

functions.

•Represent QA in interactions with internal and external contacts and Health Authorities (HA), as appropriate.

•Proactively participate in the external engagement with HA, industry activities to help shape the associated regulatory environment and continuously review compliance metrics trend from regulators/industry to incorporate into the business process to meet regulatory and business needs.

•Assist the Head RDPV QA office (DSCN) in coaching, mentoring, and training of the new QA members.

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.