CLevelCrossing
Executive Director QMS Operational Controls
CLevelCrossing, New Brunswick, New Jersey, us, 08933
Executive Director QMS Operational Controls
Posted on: Mar 31, 2020 Profile Job Information Bristol Myers Squibb Executive Director, QMS Operational Controls Location: New Brunswick, New Jersey Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience, and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration, and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. Key Responsibilities: Manage a QMS team of 4 to 8 direct reports responsible for driving requirements, development, design, implementation, and deployment of QMS processes and associated IT solutions and procedures including the establishment of performance-based metrics for 20 to 30 GMP/GDP processes supporting the product lifecycle and driving continuous improvement in the risk/compliance profile and operational performance. Build and develop the GPS Process Owner Network (Global Process Owners and Process Leads) of varying degrees of seniority and maturity (20 ED to D7s) supporting the processes in the Operational Controls pillar of the new process architecture. Build and maintain effective partnerships with senior leaders across R&D, GPS, Commercial, and enabling functions to drive endorsement of new operating model and culture changes required to sustain new model. Build required capabilities within the group around change leadership, communication, systems-thinking, culture of excellence, enterprise mindset, continuous improvement, and deep GxP/QMS expertise to deliver world-class solutions in the QMS space. Manage required consultancy firm for the processes in scope of role and associated SoWs including any required temporary staff and associated project budgets. Ensure key program milestones, risks, and mitigation plans are in place including securing completion of all regulatory commitments. Outcome of this role is a direct effect on establishing and maintaining required satisfactory quality and compliance posture in the GxP space to ensure BMS can continue to conduct clinical trials, improved ability to register our products globally by improving inspection performance and quality reliability in the commercial manufacture/distribution of products. Deliver long-term enhanced value balancing cost-speed-quality. 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 the resources to pursue their goals, both at work and in their personal lives. Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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Posted on: Mar 31, 2020 Profile Job Information Bristol Myers Squibb Executive Director, QMS Operational Controls Location: New Brunswick, New Jersey Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience, and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration, and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. Key Responsibilities: Manage a QMS team of 4 to 8 direct reports responsible for driving requirements, development, design, implementation, and deployment of QMS processes and associated IT solutions and procedures including the establishment of performance-based metrics for 20 to 30 GMP/GDP processes supporting the product lifecycle and driving continuous improvement in the risk/compliance profile and operational performance. Build and develop the GPS Process Owner Network (Global Process Owners and Process Leads) of varying degrees of seniority and maturity (20 ED to D7s) supporting the processes in the Operational Controls pillar of the new process architecture. Build and maintain effective partnerships with senior leaders across R&D, GPS, Commercial, and enabling functions to drive endorsement of new operating model and culture changes required to sustain new model. Build required capabilities within the group around change leadership, communication, systems-thinking, culture of excellence, enterprise mindset, continuous improvement, and deep GxP/QMS expertise to deliver world-class solutions in the QMS space. Manage required consultancy firm for the processes in scope of role and associated SoWs including any required temporary staff and associated project budgets. Ensure key program milestones, risks, and mitigation plans are in place including securing completion of all regulatory commitments. Outcome of this role is a direct effect on establishing and maintaining required satisfactory quality and compliance posture in the GxP space to ensure BMS can continue to conduct clinical trials, improved ability to register our products globally by improving inspection performance and quality reliability in the commercial manufacture/distribution of products. Deliver long-term enhanced value balancing cost-speed-quality. 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 the resources to pursue their goals, both at work and in their personal lives. Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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