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Director, Therapeutic Area Quality Lead

Posted on Apr 6, 2021 by Bristol-Myers Squibb

Princeton, NJ 08540
Immediate Start
Annual Salary

Job Description
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.

Key responsibilities of the Director, Therapeutic Area Quality Lead include: 1) Design and implement end-to-end quality strategy for respective Therapeutic Area 2) Ensure successful Health Authority (HA) engagement ; 3) Manage for cause, critical and/or complex quality issues as well as serious breaches for the TA; 4) Engage in appropriate activities to support product submissions; 5)Establish strong partnership with business stakeholder.

Design and implement the quality strategy for the 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 consequences 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
Seek to understand and evaluate their priorities
Actively participate in and make meaningful contributions
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
Demonstrate implementation of quality strategy to Health Authorities
Sharing the quality plan to Health Authorities
Prepare for inspections and support inspections
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
Experience - Responsibility and minimum number of years

Minimum 10 years QA experience or relevant experience in medical quality management, biomedical science, clinical development, or regulatory compliance
Competencies - knowledge, skills, abilities, other

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

Reference: 1152693875

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