Associate Director – Therapeutic Area Quality

Associate Director – Therapeutic Area Quality

Requirements

• B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training, and experience
• Minimum 10 years QA experience or relevant experience in medical quality management, biomedical science, clinical development, or regulatory compliance
• Demonstrated applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance
• Very experienced in nonclinical/clinical research/pharmacovigilance experience
• 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 (Oncology, Cardiovascular, Hematology, Cell Therapy and Immunology and Fibrosis)
• 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.

Responsibilities

• Design, develop and implement the Clinical Audit Strategy for various Therapy Areas (ICN & HOCT)
• Oversee the planning, conduct, and reporting of internal and external audits of clinical trial investigator sites, vendors, and process/systems, including for-cause and directed activities
• Provide input in the global audit plans based on identified signals/trends/risks/gaps
• Partner with Risk, Governance, Operations (RGO) in the development of the Quality Narrative, specifically developing and contribution the audit/inspection portion
• Apply a risk-based approach to audit planning and execution
• Participate in audits and inspections, where needed, based on experience and resource availability
• Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to Health Authorities and RGO
• Translate risk factors into Clinical Quality Assurance oversight plans, including internal and external audit strategies and inspection readiness/management strategies
• Contact with appropriate technical, supervisory and management personnel internally and externally (BMS sites, vendors, partners etc.) in the conducting and reporting of audits
• Establish strong partnership with business stakeholders
• Interactions with external auditors from partner companies and health authority inspectors during the conduct of health authority inspections
• External engagement as needed with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical company peers
• 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.

Preferred Qualifications

No preferred qualifications provided.