Associate Director, Risk Based Quality Management – RBQM

🕒 July 2

🇺🇸 United States – Remote

💵 $169.2k - $253k / year

⏰ Full Time

🟠 Senior

🎲 Risk

👻 Ghost score 33%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

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 • Lead development, enhancement, and governance of the RBQM operating model, including risk frameworks, processes, tools, and performance metrics • Drive risk-based approaches across the trial lifecycle from protocol design and risk assessment through study conduct oversight and closeout • Represent RBQM as a subject matter expert in cross-functional forums, audits, and regulatory inspections • Facilitate cross-functional risk identification and evaluation at study, program, and portfolio levels • Oversee creation, review, and maintenance of study-level Quality Tolerance Limits and evaluation and escalation of deviations • Develop Risk Management and Sponsor Oversight Plans with stakeholders • Monitor key risk indicators and performance metrics for emerging trends, quality signals, and compliance issues • Partner with Clinical Management, Monitoring Oversight, Data Sciences, and other departments on centralized monitoring and data-driven decisions • Oversee analytical reviews of operational and clinical data • Lead cross-functional data reviews and implement adjustments to risk controls • Drive continuous improvement, standardization, and quality initiatives in RBQM processes • Integrate digital tools, analytics platforms, and automation for risk detection and oversight • Support change management and RBQM training strategies • Ensure CRO and vendor alignment with RBQM requirements • Provide strategic guidance on RBQM methodologies and best practices • Ensure compliance with regulatory requirements, industry standards, and internal quality frameworks • Lead or contribute to audit and inspection preparation, responses, CAPA development, and remediation • Provide operational oversight of CROs/FSPs, consultants, and vendors • Monitor external provider performance, contractual obligations, KPIs, and regulatory requirements • Participate in vendor selection, contract negotiation, and scope definition • Support clinical operations budget development and management • Monitor expenditures, optimize costs, and collaborate on forecasting, invoicing, and financial discrepancies • Lead onboarding and training, conduct performance reviews, provide coaching, and monitor team workload and quality metrics as applicable

🎯 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 a 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 • Excellent cross-functional communication, facilitation, and influencing skills • Ability to manage multiple priorities and drive decisions in a fast-paced environment • Proficiency with RBQM tools, clinical systems, data visualization platforms, and analytics dashboards • Skilled in change leadership and process transformation • Strategic and systems-based thinker with strong planning, organizational, analytical, and problem-solving skills • Strong collaborator with a solution-oriented mindset • Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint) • Willingness to travel as required

🏖️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage • Company-provided basic life insurance • Accidental death and dismemberment insurance • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Other company-provided benefits • Incentive opportunity

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume