Associate Director, Therapeutic Area Quality

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Position Summary 

The Associate Director, Therapeutic Area Audit Strategy Lead will be mainly responsible for developing the TA audit strategy and overseeing the planning, conduct and reporting of internal and external audits of clinical trial investigator sites.  

Key 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. 

Other 

• 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