Associate Director, Therapeutic Area Quality

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 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. 

Research and Development Quality is responsible for the following: 

• Defines and oversees the global quality strategy for early R&D Development up to phase IV Projects and ensure that GxP Quality Management Systems are implemented and in use 

• Translate QMS elements into the R&D processes and ensure feedback to the central QMS team 

• Lead the Quality and Compliance R&D Escalation Process 

• Ensure GLP systems are in place, studies are audited and lead analytical path of Translational Medicine  

• Oversee the Data generation and data integrity from laboratory work and non-clinical phase projects 

• Ensure Quality is Designed into non-clinical trials and clinical protocols using data and information from discovery phase, non-clinical and clinical studies  

• Oversee process development, manufacturing and release of clinical supplies to clinical trials protocols 

• Advice on Franchises (including Cell Therapy) and Clinical Operations development projects 

• Lead Qualification of vendors and manage external Quality Systems  

• Execute GCP and Pharmacovigilance audits and support GCP and Pharmacovigilance Regulatory inspections 

• Ensure that GxP follow-up CAPA activities are completed 

• Oversee study centers, countries, investigators and connect with PV, Medical Affairs and Regulatory Affairs  

• Contribute to develop Quality Management Systems training elements     

 
Qualifications & Experience 
Education and Experience: 

• 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 

Required Competencies:  Knowledge, Skills, and Abilities 

• 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 

 #Hybrid

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 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. 

Research and Development Quality is responsible for the following: 

• Defines and oversees the global quality strategy for early R&D Development up to phase IV Projects and ensure that GxP Quality Management Systems are implemented and in use 

• Translate QMS elements into the R&D processes and ensure feedback to the central QMS team 

• Lead the Quality and Compliance R&D Escalation Process 

• Ensure GLP systems are in place, studies are audited and lead analytical path of Translational Medicine  

• Oversee the Data generation and data integrity from laboratory work and non-clinical phase projects 

• Ensure Quality is Designed into non-clinical trials and clinical protocols using data and information from discovery phase, non-clinical and clinical studies  

• Oversee process development, manufacturing and release of clinical supplies to clinical trials protocols 

• Advice on Franchises (including Cell Therapy) and Clinical Operations development projects 

• Lead Qualification of vendors and manage external Quality Systems  

• Execute GCP and Pharmacovigilance audits and support GCP and Pharmacovigilance Regulatory inspections 

• Ensure that GxP follow-up CAPA activities are completed 

• Oversee study centers, countries, investigators and connect with PV, Medical Affairs and Regulatory Affairs  

• Contribute to develop Quality Management Systems training elements     

 
Qualifications & Experience 
Education and Experience: 

• 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 

Required Competencies:  Knowledge, Skills, and Abilities 

• 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 

 #Hybrid