Manager, Quality Assurance

Job Description

R&D Quality Assurance (QA) is an independent organization that provides quality focus at each critical stage of the product development life cycle, including post

approval marketing, to ensure high-quality, safe, and effective products, contributing to the company mission of improving and saving lives around the world.

QA Clinical Quality (CQ) provide independent assurance that 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.

Primary Responsibilities:

• Leads their own specific tasks and responsibilities within a team, prioritizing time and effort towards important deliverables and producing high-quality work
• Contributes to the overall goals of the team by excelling at their individual role and taking initiative to improve their own skills
• Influences, partners and collaborates with other colleagues within and outside their team
• Prepares, conducts QA audits, 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.
• Be able to analyze and leverage critical to quality factors to identify potential risks to prepare and perform risked-based audits
• Activities may include GCP audits of investigator sites, suppliers, third party collaborations and due diligence activities.
• In alignment with risk assessments, supports the QAL in the identification of audit substrate for scheduling, as appropriate.
• 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.
• Interfaces and provides day-to-day support to applicable QA functional line to ensure appropriate quality oversight of assigned studies.
• Assesses compliance of clinical investigator sites, vendors, study activities, clinical study reports and submission documents, and Country Offices (COs) processes against ICH
• (International Conference of Harmonization), applicable government agency regulations/guidelines, as well as policies, procedures and industry standards. The QAS should have a comprehensive working knowledge of Quality Assurance, regulations and auditing. Develops and delivers awareness sessions with minimal supervision on various GCP and PV topics internally and externally.
• Promotes standardization of auditing approach within QA.
• Routinely suggests new audit techniques/aids in areas of technical expertise.
• Ensures the work climate/culture within QA, exemplifies the Leadership behaviors

Education and Experience

• BS/BA degree or above in Clinical Medicine, life science or pharmacy.
• Clinical development knowledge system, capabilities in multiple therapeutic areas or GxP quality management, and In-depth clinical regulations insight and expertise.
• Clinical audit or quality management or inspection management experience is preferred.
• Diverse working experience, including different stages of clinical research, and/or working in MNC is a plus

Required Skills:

Audits Compliance, Compliance Program Development, Crisis Management, Detail-Oriented, Ethical Compliance, Investigative Skills, Legal Regulatory Compliance, Metrics Analysis, Process Improvements, Project Risk Assessments, Regulatory Affairs Management, Regulatory Reporting, Regulatory Training, Stakeholder Management, Technical Documentation Management

Preferred Skills:

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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

09/30/2026

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