Note: The job is a remote job and is open to candidates in USA. Takeda is a patient-focused, innovation-driven company transforming the pharmaceutical industry through R&D-driven market leadership. The Associate Director, Risk Based Quality Management Operations will develop and coordinate RBQM procedures, ensuring effective risk management across study lifecycles.
Responsibilities
- Supports development of RBQM processes at the program, portfolio, and asset levels to ensure risks and issues are appropriately cascaded from higher levels to studies and escalated from study level to program level when they may impact broader outcomes
- Contributes to the creation of a lessons learned framework to ensure insights from RBQM activities are captured and applied to future studies with similar characteristics
- May represent RBQM Operations at the Global Program Team (GPT) level for priority assets, providing strategic input and risk oversight
- Assists Directors with departmental responsibilities, including study tracking and resource allocation planning
- May support quality control activities for other RBQM Operational Leads, including TMF filing, study risk assessments, and centralized monitoring actions
- Contributes to the development and interpretation of program-level reports, extracting insights that inform and enhance RBQM processes across studies
- Supports process design and adoption of risk assessment tool
- May be responsible for the implementation of RBQM procedures for assigned studies including study risk assessment and centralized monitoring
- Identifies and shares best practices, successes, case studies, failures, and process improvement opportunities to promote continuous improvement and consistency with RBQM processes
- Acts as a change agent, champion, subject matter expert and point of contact of RBQM methodology, leading study teams to understand and follow the best practices to achieve maximum benefit
- Supports inspections and regulatory interactions as it relates to Takeda’s adoption of RBQM framework
- May perform line management of other (junior) staff within RBQM Operations
Skills
- 8 or more years of experience in the pharmaceutical or CRO industry
- 3 or more years of experience in Risk Based Quality Management
- 2 or more years managerial and supervisory experience
- Robust understanding of the drug development process and clinical trial execution
- Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP)
- Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions
- Knowledge of RBQM IT systems or other data analytic systems
- Demonstrated ability to analyze data, identify patterns and make recommendations for improvement
- Demonstrated ability to effectively lead cross functional team meetings
- Experience forming cross-functional collaborations; strong interpersonal skills
- Supports a culture of continual improvement and innovation; promotes knowledge sharing
- Ability to influence without authority
- Thinks creatively; challenges the status quo
- Thinks strategically, adopts breakthrough ideas
- Encourages open dialogue
- Takes decisive action and can prioritize
- Proactively takes steps to learn and grow
- Pragmatic and willing to drive and support change
- Comfortable with ambiguity
- Excellent teamwork, organizational, interpersonal, and problem-solving skills
- Assertive and collaborative communication style
- Aptitude for data analytics; analytical mind
- Attention to detail and a critical thinker
- Embraces and demonstrates a diversity and inclusion mindset and sets an example for these behaviors for the organization
- Ability to effectively communicate cross functionally with people of various levels
Benefits
- Short-term and/ or long-term incentives
- Medical, dental, vision insurance
- A 401(k) plan and company match
- Short-term and long-term disability coverage
- Basic life insurance
- A tuition reimbursement program
- Paid volunteer time off
- Company holidays
- Well-being benefits
- Up to 80 hours of sick time per calendar year
- New hires are eligible to accrue up to 120 hours of paid vacation
Company Overview
Company H1B Sponsorship