Associate Director, Quality Risk Specialist

Role Summary

The Associate Director, RBQM - HOCT, ICN will mainly be responsible for developing the Quality Narrative at the study and/or ASSET and TA levels to document end-to-end RBQM for critical to quality (CtQ) data, processes, and vendors, demonstrating effective risk and issue management. Provide quality and compliance consultation to clinical trials teams throughout study lifecycle and establish a feedback loop to ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun.

Responsibilities

• Develop the Quality Narrative (or equivalent) at a study and/or ASSET and TA level, to document the end-to-end risk-based quality management for CtQ data, processes and vendors demonstrating effective risk and issue management.
• As part of the upstream protocol authoring process, partner with Drug Development, to embed Quality by Design principles and help identify study specific critical to quality (CtQ) data, processes and vendors and ensure adequate risk mitigation strategies have been implemented.
• During trial conduct, provide feedback on risks to study specific critical to quality factors and ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun. This will involve partnering with the CAPA CoE and Serious Breach pillar and Clinical Quality Assurance to gather input from audits, inspections, internal quality events, significant issues, and external intelligence to inform QbD.
• At the study level, conduct quality assurance spot checks to ensure risk mitigation strategies are accurately translated into operational plans.
• Assist the business in defining and establishing Acceptable Ranges/QTL and KRIs for CtQ data.
• Support for cause, critical and/or complex quality issues as well as serious breaches for the TA, where deemed necessary.
• Provide quality and compliance consultation to clinical trials teams throughout study lifecycle.
• Provide regulatory intelligence on current and upcoming regulations to ensure we remain compliant with all applicable requirements.
• Establish strong partnership with business stakeholders.
• Partner with the study teams to ensure effective management of significant quality issues/noncompliance and important protocol deviations for CtQ data, processes and vendors.
• Support the monitoring and evaluation of CtQ factors throughout the study lifecycle and adapt Quality plans accordingly.
• Provide R&D Quality expertise, critical thinking, deliver training and share best practices and lessons learned into future trials.
• 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.
• 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.
• Act as a highly credible technical/ functional expert; routinely provide technical/functional guidance/coaching to direct and indirect reports/peers within the line or crosslines.
• May influence the external environment through interactions with regulators, trade associations, or professional societies.
• Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems.

Qualifications

• B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training, and experience
• Minimum 8+ years QA experience or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance.

Required Competencies

• Demonstrated applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance
• Very experienced in Risk Based Quality Management principles.
• In-depth knowledge of applied risk-management including risk assessment, risk analysis, risk evaluation, risk reporting and communication, risk treatment and the review of continuous risk management
• Understanding of BMS's therapeutic areas - HOCT and ICN.
• Extensive experience in regulatory inspection preparation, management, and related follow-up.
• Demonstrated analytical and conceptual capability-including proficiency in utilizing data and ability to formulate clear business questions that can be answered with data.
• Proven problem-solving skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution.
• Communication Skills Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers; excellent presentation skills for compelling peer and Senior Management communication.
• Project Management Must be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.
• Considers global influences, situations, and implications when making plans or decisions, solving problems, or developing strategies.
• Responds resourcefully to changing business conditions and opportunities, proactively looking for ways the organization can adapt its plans, tactics, or strategies.
• Fosters a culture in which people continually work to improve services, and work processes.