Sr. Specialist, Quality Assurance

MSD Malaysia; Fatih; On-site; TRY 2,812,000 - 3,937,000; Full time

Job summary

MSD Malaysia is seeking an experienced QA Clinical Quality Auditor to ensure safety and data integrity in clinical trials, with emphasis on risk-based audits and analytics.

You will conduct audits, generate reports, and drive corrective actions while collaborating with Clinical Operations and QA teams. The role requires 50%–70% travel and a strong foundation in GCP and quality management.

Qualifications

• BS/BA degree or equivalent in a relevant field and/or experience in a similar QA/clinical quality role.
• Experience with QA audits, data analysis and risk-based auditing.
• Familiarity with GCP, Quality Assurance systems and deviation management.

Responsibilities

• Prepares, conducts QA audits, generates audit reports and communicates results to QA management and stakeholders.
• Interacts with teams to ensure corrective and preventative actions are closed.
• Applies data-driven approaches and quality metrics to detect trends and prioritize audits.
• Supports GCP audits of investigator sites, study level, suppliers and third party collaborations.
• Travel 50% - 70%.

Skills

Ownership and Accountability

Execution Excellence

Networking and Partnerships

Coaching and Development

Talent Growth

Education

BS/BA degree or equivalent

Job description

Job Description Our Research & Development Division QA Clinical Quality (CQ) provide 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.

Primary Responsibilities

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 Applies data-driven approaches, including the use of analytics dashboards and quality metrics, to detect trends, prioritize audit focus areas, enhance risk-based decision making, and deliver value-added insights that support continuous quality improvement.

Influences, partners and collaborates with other colleagues within and outside their team Activities may include GCP audits of investigator sites, study level, suppliers, third party collaborations and due diligence activities.

Travel 50% - 70%

Skills

• 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 relative to the Auditor Resource include

Support, advance, and drive the Clinical Quality capacity planning and assignment of GCP audits

Education

BS/BA degree or equivalent and/or experience in a relevant field, along with proficiency in the primary activities and essential skills required for this role.

Notes: Multiple locations in Europe. Additional locations in Europe might be considered.

Required Skills

Audits Compliance, Data Analysis, Detail-Oriented, Deviation Management, Leading by Influence, Process Improvements, Quality Assurance Systems, Quality Risk Management, Technical Writing

Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Remote Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 09/17/2026 *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.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.