Director, Therapeutic Area Quality Lead
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The main responsibility of the Director, Therapeutic Area (TA) Quality Lead will be to create a Quality Strategy and oversight within the Oncology therapeutic area and deliver the full range of quality related activities to support.
Design and implement the quality strategy for the Oncology Therapeutic Area
Independently assess specific risk areas - brings ideas and strategies to the forefront and propose modifications to the Quality Assurance Program where necessary
Identify and drive continuous quality process improvements as a consequence of audits, assessments, inspections, trends/metrics and root cause analysis
Drive implementation of Quality by Design principles
Develop, implements and maintain the program quality plan summarizing the quality strategy by summarizing the result of evidence of quality activities
Integrate end –to end quality principles and review project milestones with R&ED/GDD
Establish strong partnership with business stakeholder
Deliver independent expert support and propose solutions
Lead the presentation of key data (compliance, conformance, issues and risks) to drive decision making
Manage for cause, critical and/or complex quality issues as well as serious breaches for the TA
Initiate appropriate activities to support product submissions
Ensure successful Health Authority engagement
Participate/provide expertise in in licensing activities as applicable
Provide guidance and training on relevant GxP regulations and guidelines to cross-functional business partners
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
Considers global influences, situations, and implications when making plans or decisions, solving problems, or developing strategies
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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