Associate Director, Quality Assurance

MSD•Upper Gwynedd Township, PA

3d•$129,000 - $203,100•Remote

About The Position

Our Research & Development Division QA Clinical Quality (CQ) provides independent assurance that our Company ensures the safety, rights, and well-being of participants, while complying with applicable global regulatory requirements through sound processes, procedures, and strategies for ensuring data integrity in our clinical trials.

Requirements

Minimum of 5 years of experience in a relevant field.
Accountability
Accountability
Action Plan Development
Adaptability
Audit Management
Building Partnerships
Compliance Investigations
Deviation Management
Global Program Development
Impact Analysis
Influencing Skills
Proactive Behavior
Proactive Thinking
Project Leadership
Project Risk Assessments
Quality Assurance Processes
Quality Assurance Systems
Quality Auditing
Quality Oversight
Quality Reporting
Quality Risk Management
Quality Systems Compliance
Regulatory Compliance
Results-Oriented
Setting Performance Standards
Influence/Negotiation - Using effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes.
Ownership and Accountability - Taking ownership; setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposed.
Execution Excellence - Taking prompt action to accomplish work goals, per compliance standards; taking action to achieve results beyond what is required; being proactive.
Networking and Partnerships - Building partnerships; developing and leveraging relationships within and across work groups to achieve results.
Coaching and Development- Building self-insight; demonstrating an awareness of own strengths and development needs as well as the impact of own behavior on others; modifying behavior based on self-awareness to improve impact.
Talent Growth - Embracing continuous learning; actively identifying new areas for growth; regularly creating and taking advantage of learning opportunities; using newly gained knowledge and skills on the job and learning through their application.

Responsibilities

Prepares, conducts QA audits, including prolonged auditing in China, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders (e.g. Clinical Operations), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
Collaborate with colleagues in China to understand cultural considerations, responsibilities for work in global studies and local regulations in the China related to GCP and new drug applications.
Able to analyze and leverage critical to quality factors to identify potential risks to prepare and perform risk-based audits.
GCP routine and directed audits of investigator sites, country offices, suppliers, third party collaborations and due diligence activities.
In alignment with risk assessments and input from Japan/China Lead, support the QALs in the identification of audit substrate in China for scheduling, as appropriate.
Ability to travel to/within China; extended stay in country (2-3 weeks per quarter).
Facilitates communication and alignment with key stakeholders related to quality events and audit findings.
Participate in Significant Quality Issues management for assigned studies, including assessment of potential root causes and remediation (corrective and preventative actions) as deemed appropriate by the QAL.
Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL and TA Head.