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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Search Firm Representatives Please Read Carefully
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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