Director, Development Quality Lead, Neuroscience

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Position Summary

Director, Development Quality – Neuroscience, will mainly be responsible for designing, developing, and implementing risk-based quality management strategies to identify, assess, and mitigate risks throughout the clinical trial process. This ensures compliance with regulatory requirements, maintains the reliability and interpretability of trial results, safeguards patient safety, and upholds the quality of study data.

Key Responsibilities

·       Ensure Quality Strategies for Neuroscience portfolio are developed to avoid, detect and address serious non-compliance with GCP, the trial protocol and applicable regulatory requirements to prevent recurrence.

·       Oversee development of the Quality Narrative (or equivalent) at the ASSET / TA level, to document the end-to-end risk-based quality management for CtQ data, processes and vendors demonstrating effective risk and issue management.

·       Manage a team of Asset Quality Leads and oversee team performance, provide guidance and development opportunities, ensuring operational efficiency and alignment with departmental and organizational objectives.

·       Partner with the Drug Development organization to drive adoption of Quality by Design principles across BMS protocols to ensure quality is built into the scientific and operational design and conduct of clinical trials.

·       Ensure risks to critical to quality factors are managed prospectively and adjusted when new or unanticipated issues arise once the trial has begun.

·       Provide leadership, guidance, development and coaching to the R&D Risk Management team for management of significant quality issues.

·       Lead for-cause, critical and/or complex quality issues as well as serious breaches for the TA, if needed.

·       Provide R&D Quality expertise, critical thinking, and partner with Drug Development to deliver training and education (e.g., use cases, best practices, road shows, etc.) to support effective RBM practices.

·       Establish strong partnerships with business stakeholders and participate in GPT / CDT / other relevant governance committees for the ASSET. Preferably from ID-2 (Go to Development) or ID-3 (Go to POC).

·       Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to the business and Health Authorities, as needed.

·       Define, own, and execute R&D Quality processes contributing to Drug Development’s end-to-end Risk Management framework across the clinical trial portfolio.

·       Ensure compliance with ICH (E8, E6, E9) and other relevant regulatory requirements.

·       External engagement as needed with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical company peers.

Other

• Drive quality into the business through proactive quality support, mentoring and/or coaching and consultation.

• Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level.

• Lead multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline.

·       Lead and/or contribute to the implementation of large-scale initiatives and/or organizational changes (such as functional optimization) that affect the department.