Job Description
Our Quality Assurance (QA) organization is an independent body that focuses on quality at every critical stage of the product development lifecycle. By ensuring high-quality, safe, and effective products—including post-approval sales activities—we contribute to the company's mission of improving and saving lives around the world.
Our QA Clinical Quality (CQ) team provides independent assurance that we are protecting the safety, rights, and welfare of clinical trial subjects while complying with applicable global regulatory requirements through the assurance of appropriate processes, procedures, strategies, and data integrity.
Primary Responsibilities:
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Conduct routine and directed GCP audits of clinical trial sites in Japan and the APAC region. As needed, coordinate with Country Offices, suppliers, and co-development partners, and perform due diligence activities.
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Prepare for and conduct QA audits, draft audit reports, and report findings to QA management and relevant stakeholders (e.g., Clinical Development departments). Additionally, collaborate with relevant departments to ensure Corrective and Preventive Actions (CAPA) are appropriately implemented and findings are closed.
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Analyze and utilize Critical to Quality (CtQ) factors to identify potential risks and develop and implement risk-based audit plans.
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Evaluate the compliance of clinical trial sites, suppliers, clinical development departments, clinical study reports, submission documents (as needed), and Country Office (CO) processes based on ICH (International Council for Harmonization), applicable national regulatory authority regulations and guidelines, as well as company policies, procedures, and industry standards. Plan and conduct educational sessions on various GCP and PV topics internally and externally with minimal supervision.
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Escalate matters involving quality issues, potential misconduct, or significant deviations that could impact projects/products to the QAL and TA Head appropriately and promptly.
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Collaborate with relevant QA functional teams to provide daily support, ensuring an appropriate quality management system is maintained for assigned trials.
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Based on risk assessments, support the QAL in identifying audit targets and developing audit plans as needed.
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Contribute to the development and improvement of QA procedures, guidance documents, and audit tools to ensure global consistency within the QA department.
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Promote the standardization of audit approaches within the QA department. Continuously propose new audit methodologies and support tools in technical areas of expertise.
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Actively participate in special assignments for various project teams as determined by QA management.
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Provide training and mentoring to less experienced QA members.
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Coordinate and support the daily operations of staff by providing guidance, assigning tasks, and ensuring productivity and engagement. Address performance issues and opportunities for improvement to support staff growth and development.
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Maintain and foster a positive workplace culture within the QA department and embody the company's leadership behaviors. Communicate smoothly and facilitate collaboration with key stakeholders at all levels.
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Serve as the QA point of contact for the development department in Japan, providing guidance on QA operations within Japan.
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Collaborate with stakeholders in Japan to provide daily support as a member of the Quality Management Unit (QMU).
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During PMDA inspections, cooperate with relevant departments to respond to inquiries within the scope of assigned audit responsibilities.
Required Skills
Education
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Bachelor's degree (BS/BA) in a science or liberal arts field or equivalent education is preferred.
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5+ years of relevant work experience.
Experience
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5+ years of practical experience in GCP (clinical trial) auditing at a pharmaceutical company or CRO.
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Practical knowledge of ICH-GCP, the Japanese PMD Act, and clinical trial-related regulations in major jurisdictions (e.g., FDA, EMA).
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Knowledge of clinical development. Understanding of the entire clinical trial process, including protocol creation, ethics review, informed consent, subject selection/enrollment, data collection/management, monitoring, investigational product management, handling of serious adverse events, data cleanup, and clinical study report preparation.
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Experience in clinical site auditing. Practical experience in audit planning, audit execution, audit report writing, and proposing/following up on Corrective and Preventive Actions (CAPA).
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Experience working in global teams or multinational projects, or a strong willingness and adaptability to work in a global environment.
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Line management experience is a plus.
Language Skills
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Japanese: Native level required. Ability to communicate accurately and professionally, both orally and in writing, with external parties (including investigators) and internal teams.
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English: Business level or higher. Ability to participate in and lead meetings in English, handle email correspondence, and create documents/presentations in English. Ability to write audit reports in English, or experience conducting audits in English, or the ability to conduct audits in English. Ability to conduct Audit Debriefing Meetings in English.
Enterprise Leadership Skills
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Influence: The ability to gain understanding, buy-in, and commitment to action for ideas that support specific business outcomes using effective engagement and persuasion techniques.
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Motivation and Inspiration: The ability to communicate effectively, conveying information and ideas clearly and concisely in a way that is easy for others to understand and remember. Active listening skills.
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Ownership and Accountability: Taking personal responsibility and setting high standards of performance for oneself and others. Taking responsibility for successfully completing assigned tasks and challenges. A mindset of seeking high standards internally rather than having them imposed externally.
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Execution Excellence: Acting quickly to achieve business goals in line with compliance standards. Taking initiative to achieve results beyond what is required.
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Networking and Partnerships: The ability to build and leverage relationships within and outside business groups to achieve results.
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Coaching and Development: Deepening self-awareness, recognizing one's own strengths, growth areas, and the impact of one's behavior on others. Modifying behavior based on self-awareness to increase influence on others.
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Talent Growth: Embracing continuous learning, proactively finding new growth opportunities, and continuously utilizing learning opportunities. A mindset of applying newly acquired knowledge and skills to work and continuing to learn through practice.
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Diversity and Inclusion: Respecting differences and working effectively with people of diverse cultures, interpersonal styles, perspectives, motivations, and backgrounds. Actively drawing out and incorporating unique abilities, insights, and ideas from a diverse workforce.
Required Skills:
Accountability, Audits Compliance, Business Partner Support, Clinical Quality Assurance, Clinical Reporting, Data Analysis, GCP Auditing, Investigative Auditing, Process Audits, Quality Assurance (QA), Quality Risk Management, Validation Processes, Vendor Audits
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:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
03/31/2027
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