Senior Manager, Global Clinical Quality Management

Job Summary The Senior Manager of Global Quality Management (GQM) plays a critical role in driving clinical quality initiatives to ensure adherence to Good Clinical Practice (GCP), regulatory standards, and internal protocols across international clinical trials. This position offers a unique opportunity for hands-on quality oversight and involvement in audit preparation, working closely with various internal teams and external partners to uphold exceptional quality benchmarks throughout the clinical development lifecycle. Key Responsibilities Clinical Study Support Act as a GCP quality advisor for clinical teams during study planning, execution, and closure. Assist in the review of essential study documents (e.g., protocols, monitoring plans, vendor agreements) to ensure quality and compliance. Identify and help resolve quality-related issues, protocol deviations, and areas of potential non-compliance. Collaborate with Clinical Operations, Regulatory Affairs, and Medical Affairs to integrate quality practices throughout the study lifecycle. Inspection Readiness Support activities aimed at ensuring inspection readiness, including conducting mock audits, reviewing documentation, and coordinating training. Maintain tools and trackers for inspection readiness, in addition to communication plans. Participate in regulatory inspections and assist in the preparation of response documents. Audit Program Execution Contribute to the creation of the annual audit plan using risk-based methodologies. Coordinate and facilitate audits of investigator sites, vendors, and internal processes. Track audit findings and ensure prompt implementation of corrective and preventive actions (CAPAs). Monitor audit trends and report recurring issues to senior leadership. Quality Systems & Compliance Assist in the implementation and ongoing enhancement of clinical quality systems, standard operating procedures (SOPs), and related policies. Support in managing deviations, conducting root cause analyses, and tracking CAPAs associated with clinical activities. Keep abreast of changes in global GCP regulations and industry best practices. Collaboration & Team Support Partner with internal stakeholders and Contract Research Organizations (CROs) to ensure consistent quality oversight. May mentor junior team members or contractors to foster professional growth. Engage in cross-functional initiatives aimed at promoting a culture of quality and compliance. Qualifications Required Bachelor's degree in life sciences or a related field; an advanced degree is an advantage. 6-8 years of experience in clinical quality assurance or clinical research in the pharmaceutical or biotechnology sectors. Strong knowledge of GCP, ICH guidelines, and global regulatory standards. Experience in supporting inspection readiness and participating in audits or inspections. Excellent communication, organizational, and problem-solving skills. Willingness to travel domestically and internationally as required. Proficient in MS Office Suite (Word, Excel, PowerPoint). Preferred: Experience with TrackWise or similar quality management systems. Previous collaboration with CROs and external vendors. Familiarity with FDA or other health authority inspections. Competencies Accountability for Results: Demonstrate focus on strategic objectives, uphold high performance standards, and actively lead change initiatives. Strategic Thinking & Problem Solving: Make decisions considering the long-term implications for customers, patients, employees, and the business. Patient & Customer Centricity: Maintain a continuous emphasis on the needs of customers and key stakeholders. Impactful Communication: Communicate logically, clearly, and respectfully; influence at various levels to achieve optimal outcomes. Respectful Collaboration: Value diverse perspectives and strive for partner engagement to reach common goals. Empowered Development: Actively engage in personal and professional development as a priority. Compensation Range: Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity. The specified range is indicative of the typical pay for this role within the United States and may be influenced by factors such as the candidate's experience and specific skills. Typically, the starting pay aligns within this range rather than at the minimum or maximum. This information is provided to candidates as per state and local regulations. Application Deadline: This position will be openly advertised for at least 5 business days. Company Benefits: Enjoy comprehensive medical, dental, and vision coverage, along with prescription drug benefits, basic life insurance, short and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and other valuable programs. Discover more about Otsuka and our benefits offerings. Disclaimer: This job description outlines the general nature and level of work performed in this position. It is not intended to include every specific duty and responsibility associated with the role. Otsuka reserves the right to amend responsibilities to meet business and organizational needs. Otsuka is an equal opportunity employer and welcomes applications from all qualified individuals regardless of race, color, sex, gender identity, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. Qualified individuals with disabilities or disabled veterans may request reasonable accommodations if they are unable or limited in their ability to apply for this position due to their disability. Requests for accommodations can be directed to Accommodation Request. Statement Regarding Job Recruiting Fraud Scams: Otsuka prioritizes the security and protection of your personal information. Be aware that individuals may falsely present themselves as company representatives to gain access to personal information or solicit money by offering fictitious job opportunities. Otsuka will never ask for financial information or payment during the application process, nor will we require you to pay for equipment or any other expense related to job applications. If you are approached with such requests, they should be reported immediately. To ensure you are engaging with a legitimate opportunity at Otsuka, apply only through our official career websites. 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Created: 2026-03-12