岗位职责：

Proactive Quality Approach

•        Provide proactive QA guidance and quality support to Clinical Safety & Pharmacovigilance (CSPV) activities, ensuring comprehensive compliance oversight, closely aligned with the Regional Head of PV QA.

•        Implement Quality by Design strategies through involvement in CSPV projects and initiatives across the local organization, quality review of the relevant procedural documents, etc.

•        Perform quality review of key CSPV regulatory documents, including the QA-related sections of

the local Pharmacovigilance System Master File (PSMF), as applicable, and ensure adherence to local and global safety reporting timelines.

•        Monitor local regulatory trends and industry best practices to align the local QMS roadmap

with changing needs.

•        Review risks by evaluating Quality Events, audit outcomes, and metrics (KPIs/KQIs),

•        Present risk areas and mitigation strategies to stakeholders via the Quality Review Board

(QRB) or similar local management review forums.

Quality Investigation

•        Act as quality partner in the investigation and resolution of Quality Events related to PV system, overseeing the formulation of corrective and preventive actions (CAPA), including Root Cause Analysis (RCA), and monitoring their progress to ensure timely closure,

•        Ensure timely escalation of critical issues to PVQA leadership team.

Audit Support & Inspection Readiness

•        Collaborate with Global Audits and Compliance (A&C) group to support the execution of audit

programs and oversee the monitoring of resulting findings and associated Corrective and Preventive Actions (CAPAs).

•        Serve as the primary QA Point (Inspection Management Team (IMT) Lead) of Contact for Health

Authority inspections and License Partner audits as assigned.

•        Lead inspection readiness activities, including preparing local teams and managing post-inspection follow-up in accordance with company standards and local regulations.

•        Coordinate and support CSPV teams in adequately preparing for License Partner audits, as applicable.

Promote Quality Culture & Drive Continuous Improvement

•        Facilitate knowledge management initiatives,

•        Organize sharing of Best Practices and Lessons Learned from audits, inspections, regulatory intelligence,

•        Develop, deliver and monitor training for necessary stakeholders, ensuring awareness and understanding of quality and compliance requirements.

•        Partner with local Legal, Regulatory Affairs, Medical Affairs and Clinical Safety & PV (CSPV) teams to address compliance concerns. Collaborate with the Global Audits and Compliance group, Development and Medical Affairs QA, Quality Management Systems QA and GMP QA as needed.

•        Identify areas for process improvement by evaluating audit outcomes and data interpretation, delivering risk-based recommendations to leadership and actively engage in process improvement activities.

Others

This role is dedicated to activities in the assigned territories in APAC but may be assigned to support any global activities to support R&D PVQA objectives as deemed necessary.

任职资历：

1.      Minimum Bachelor’s degree in Life Sciences, Pharmacy, or related discipline.

2.      Minimum 10 years in the bio/pharmaceutical industry with at least 5 years in a GvP environment.

3.      Experience as a PV QA Auditor is a significant advantage

4.      Expertise in QMS, Knowledge of international, regional and local PV regulations.

5.      Competency: Ability to work in a matrix environment, influencing outcomes through relationship building and diplomatic communication. Good interpersonal and negotiation skills, problem solving skills.

6.      Ability to travel up to 15% (regional and occasional global travel).

7.      Fluent in English and Mandarin Chinese as applicable to the site.

8.      Microsoft Office Suite