Director R&D Quality Compliance Risk Mgt

Role Summary

The Director of R&D Quality Compliance & Risk Management provides centralized leadership and expertise across R&D Quality functions to drive data-driven proactive compliance & risk management. This role oversees R&D Quality execution of processes for ensuring compliance with global regulations, documentation/communication/mitigation of risks, and reporting/trending of metrics. The Director of R&D Quality Compliance & Risk Management contributes to organizational success through strong individual leadership, collaboration, and fostering a culture of compliance and continuous improvement.

Responsibilities

• Partner cross-functionally to enable transparency & evaluation of R&D Quality risks and issues, collaborating with functional leads to address challenges and constraints. Provide enterprise-wide assessments and risk-based rationale to facilitate decision-making, demonstrate sound judgment, and support the development and execution of effective and comprehensive action plans to address risks.
• Lead the implementation & management of an aligned Quality Risk Management program in R&D Quality. Provide assessment, insight and recommendations on risks across the R&D enterprise to senior R&D Quality management.
• Serve as a key collaborator to R&D Quality personnel on compliance issues, preparation for audits/inspections, regulatory risk assessments, and process improvement opportunities.
• Develop and oversee appropriate R&D Quality metrics reporting on the state of compliance across the R&D enterprise. Identify and drive continuous quality process improvements and risk mitigations through assessment of audit & inspection findings, quality event outcomes, and identification of trends.
• Partner with Global Quality Compliance and Systems as R&D Quality business process owner for the regulatory intelligence process. Ensure robust implementation and execution of the process within R&D Quality to maintain compliance with complex and evolving global regulations.
• Collaborate with R&D Quality leads to coordinate the information flow and consolidation of functional Quality Councils into a enterprise-wide view, extract critical data/issues/risks, and develop an executive-level assessment for review and dissemination by the Senior Director of R&D Quality Compliance, Systems, and Data.
• 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

• Bachelor’s Degree in Chemistry, Biology, Engineering or related field
• 10+ years of increasing responsibility and experience in the biopharma/biotech industry
• 8+ years of Quality/Compliance experience

Education

• Minimum requirements

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.