Director, Quality Assurance

Job Description

#Clinical Quality
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. The QA Head, China will ensure quality principles are considered throughout the drug development process, risk mitigation strategies for programs underway are implemented and quality metrics, including audits, are utilized to inform the business of the state of quality of the programs within their respective therapeutic area and across China R&D functions. The R&D QA Head, China will utilize audit and inspection intelligence and risk mitigation plans to assure adherence to Good Clinical Practice (GCP) in the conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of study participants. This role will be responsible to perform risk assessments to identify audit targets in collaboration with QA TA Heads, conduct audits, develop and maintain audit tools, as well as, review audit reports. They will work to assure quality standards are consistently applied and will escalate resource and data quality matters to Senior Management as appropriate. This role will also enable cross functional and local QA activities with respect to vendor, laboratory qualification and support activities, as well as business partner functions in Pharmacovigilance and Medical Affairs. In addition, this role will be key in ensuring excellence in communication between the China R&D and Quality Leadership teams. The QA China Head will foster and build relationships with key local stakeholders such as GCTO, GDMS and other key R&D functional areas in support of clinical trial activities and quality outcomes.

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.

Maintains robust audit and quality assurance oversight plans for local and regional activities in support of clinical trials, contributes to the QA strategy and through collaboration with stakeholders, R&D QA Clinical Head and R&D QA TA Heads, refines and adjusts strategies and plans as needed.

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.

Skills:

Primary skills include but are not limited to:

Collaboration and Partnering: Demonstrates advanced ability to work in partnership with others (within R&D QA and external to R&D QA) to accomplish quality goals; possesses advanced leadership skills.

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.

Strategic Thinking: Demonstrates advanced skills to drive change that enhances processes within R&D QA or across areas within R&D to improve quality and /or add value to the business.

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.

Business Operations/Knowledge of Field: Demonstrates advanced level of knowledge of regulations and business trends and applies this knowledge to optimize daily activities and make appropriate decisions that improves the quality of business and functional area outputs.

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.

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

10/1/2024

*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.

Job Posting End Date:10/01/2024

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.

Requisition ID:R302558

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