Associate Director, Risk Based Quality Management

🕒 July 2

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• Develop, implement and optimize RBQM frameworks across the clinical trial portfolio • Ensure proactive detection, assessment, and mitigation of operational, data quality, and patient safety risks • Partner across Clinical Management, Data Management, Biostatistics, Quality Assurance, Safety, and external vendors • Lead the development, enhancement, and governance of the RBQM operating model • Drive adoption of risk‑based approaches across the trial lifecycle • Provide guidance regarding and/or facilitate cross‑functional risk identification and evaluation • Oversee creation, review, and maintenance of study‑level Quality Tolerance Limits • Monitor key risk indicators and performance metrics • Drive continuous improvement initiatives • Ensure alignment and compliance of CROs and vendors with RBQM requirements • Lead audit and inspection preparation, responses, CAPA development, and remediation activities

🎯 Requirements

• Bachelor’s degree in life sciences or related field, advanced degree preferred • Minimum 8 years of experience in the pharmaceutical/biotechnology industry, preferably within Trial/Clinical Operations or related function associated with RBQM activities • Strong experience in risk‑based quality management, centralized monitoring, or clinical data analytics • Demonstrated leadership in implementing RBQM in a global clinical trial setting • Familiarity with ICH E6(R2/R3), ICH E8(R1), GCP, and global regulatory expectations • Deep understanding of clinical trial processes, operational risk, and data quality principles • Skilled in interpreting clinical and operational data to identify trends and quality signals • Proficiency with RBQM tools, clinical systems, data visualization platforms, and analytics dashboards • Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint)

🏖️ Benefits

• Comprehensive medical, dental, vision, prescription drug coverage • Company provided basic life, accidental death & dismemberment • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • A generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs as well as other company provided benefits