MSD Director Quality Assurance 

China, Beijing, Huairou District 

120562080

Job Description

Position Overview: Basic Functions & Responsibilities

Essential functions include but are not limited to: working independently, with limited guidance to ensure implementation and management of the Quality Assurance strategy for China across Therapeutic Areas (TA) for multiple programs and indications. TheQA Head, ChinaR&D QA Head, China

Primary Activities:

Primary activities include but are not limited to:

Develop skills, train and mentor R&D QA China staff related to audit strategy, conduct and report writing.

Be an active and integral member of the China LT and provide guidance and recommendations from QA relative to new regulations, GCP requirements and determine level of QA support for China Quality initiatives.

Provides QA strategic guidance to both internal and external stakeholders in China.

Responsible for practical knowledge of current and emerging global guidelines and regulations in China, relevant regulatory approaches and actions and status of competitor/similar products/projects to effectively develop and advance QA strategies.

Building strong relationships with all LT functions across R&D QA organization.

Identifies areas of greatest risk, through intelligence gathering (e.g., data trends, identified quality issues, regulatory intelligence), to proactively and accurately address and complete risk- based QA assessments and influence the implementation of robust mitigation strategies.

Lead and manage a range of GCP and/or Good Pharmacovigilance Practice (GPVP) audits, local/regional vendor audits, including complex audits (i.e., directed, for-cause), for a given program and/or across programs for the APAC region and in China.

Interfaces with relevant stakeholders, including regulatory, clinical and development, as appropriate, to provide Good Clinical Practice, Pharmacovigilance QA expertise. Support the Significant Quality Issue management process related to issues related to China and the AP region, including assessment of potential root causes and remediation (corrective and preventative actions).

Develops and enhances QA procedures, guidance documents and audit tools to ensure consistent global QA practices.

Ensures rapid communication of QA issues including potential misconduct or issues of significant deviation within project/products to appropriate leaders and colleagues.

Provides inspection management support as needed.

Manage personnel or assist with the management of personnel and planning functional group activities to achieve functional area and/or departmental objectives, as applicable.

Provides guidance and collaborates with QA Associate Directors, and QA Specialists, as appropriate, to assure adequate audit focus and timely knowledge transfer.

Primary skills include but are not limited to:

Communication Skills: Demonstrates expert communication skills to convey and receive information. Demonstrates advanced oral and written communication skills.

Problem Solving: Demonstrates advanced skills in problem solving using creative thinking, gathers data from appropriate stakeholders and responds to new, complex or problematic situations to influence organization direction.

Project Management:Demonstrates advanced ability to organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations.

Decision Making:Demonstrates advanced skills to utilize knowledge, networks and data to make rapid and appropriate decisions and to determine when escalation of issues is necessary.

Regulatory and Compliance Management:Demonstrates advanced knowledge of regulations and regulatory trends to ensure R&D QA and appropriate functional areas within R&D are compliant with regulations and appropriate procedures and policies and proactively manages and mitigates risks to achieve quality outcomes.

Education/Experience: BS/BA degree in relevant area with extensive experience in field and knowledge of therapeutic area.

Current Contingent Workers apply

Not Applicable

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.