Director, R&D Quality Process Operations

Role Summary

The Director of R&D Quality Process Operations provides centralized leadership and expertise across R&D Quality functions to drive the operationalization and oversight of key Global Quality processes. This role oversees several key processes in R&D Quality and partners with RDQ functional leads for successful execution. The Director contributes to organizational success through strong leadership, collaboration, and fostering a culture of compliance and continuous improvement.

Responsibilities

• Ensure R&D Quality oversight/compliance processes (e.g., supplier quality, incident management, due diligence) are robust and align with Global Quality (GQ) processes and applicable regulatory requirements.
• Lead organizational analysis and review of external supplier compliance/quality performance, consolidating data from across the R&D Quality functions to present a holistic data-driven view of risks and areas of heightened focus. Ensure compliant and timely conduct of audits, reporting, and follow-up per global and local procedures.
• Oversee R&D Quality incident escalation and management process, deliver clear and concise information to senior management and partner with stakeholders where needed to ensure robust investigations, resolution of quality issues, and implementation of effective CAPAs.
• Serve as primary liaison to Global Quality for due diligence/acquisition/divestment GxP activities. Coordinate the assignment of R&D Quality functional SMEs for assessments/activities. Lead R&D Quality post-acquisition compliance assessment activities.
• Serve as R&D Quality lead to ensure oversight and compliance with Takeda records management requirements across the organization.
• Partner with Global Quality Compliance and Systems to align on strategies for revisions to global processes, represent R&D Quality interests, and ensure connectivity of R&D Quality SMEs to GQ workstreams where needed.
• Partner with R&D Quality leaders and functions to lead change management strategies and support the evolution of new ways of working, in alignment with desired organizational goals.
• Support the development and implementation of multi-year organizational strategy for the R&D Quality Compliance, Systems, and Data organization.
• Undertake additional duties as assigned in order to contribute to the overall success of the organization.

Qualifications

• Required: Bachelor’s Degree in Chemistry, Biology, Engineering or related field
• Required: 10+ years of increasing responsibility and experience in the biopharma/biotech industry
• Required: 8+ years of Quality/Compliance experience
• Preferred: Advanced degree in Chemistry, Biology, Engineering or related field
• Preferred: Prior people-management experience

Skills

• In-depth knowledge of global regulations governing biopharmaceutical research & development as well as the role of Quality Management Systems, with the ability to effectively translate and articulate strategies to ensure compliance.
• Knowledge and understanding of the use of data visualization and analytics to monitor performance, drive improvements, and enable data-driven decision making.
• Proven leadership, collaboration, and influencing skills, coupled with a demonstrated ability to solve problems and drive impactful change.
• Proficiency in working with diverse individuals across all organizational levels.
• Exceptional interpersonal, verbal, and written communication skills, enabling successful interaction with stakeholders across the enterprise.
• Adaptability and flexibility to thrive in dynamic environments, along with the ability to manage and deliver multiple projects on time.
• Strong attention to detail and organizational expertise, with a capacity to work independently across global settings, navigate organizational complexities, and influence without authority.

Education

• Bachelor’s Degree in Chemistry, Biology, Engineering or related field
• Advanced degree in Chemistry, Biology, Engineering or related field