Field Quality, QA Manufacturing Operations Manager Fulltime

Bristol Myers Squibb에서 우리는 과학을 통해 환자의 삶을 변화시키는 단일 비전에서 영감을 받았습니다. 종양학, 혈액학, 면역학 및 심혈관 질환과 업계에서 가장 다양하고 유망한 파이프 라인 중 하나 인 우리의 열정적 인 동료들은 의미있는 변화를 주도하는 혁신에 기여합니다. 우리는 우리가 개척하는 모든 치료에 인간의 손길을 가져옵니다. 우리와 함께하고 변화를 만드십시오. Location: Devens, Massachusetts Working with Us Challenging. Meaningful. Life-changing. Those are not words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You will get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. 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. Read more: careers.bms.com/working-with-us Qualifications & Experience: Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred. A minimum of 8 years experience in biopharmaceutical quality, with a minimum of 2 years of management responsibility and 2 years of quality and compliance functions is preferred. Knowledge of biotech bulk and finished product manufacturing, Drug Substance or Drug Product disposition and batch record review is highly desirable. Knowledge of US and EU cGMP regulations and guidance. Knowledge of electronic systems including any of the following: SAP, LIMS, QMS, and electronic batch recording systems, is desirable. Microsoft Office suite knowledge and proficiency with Excel is desirable. Strong background and demonstrated effectiveness in quality assurance operation and compliance of commercial biologics manufacturing with direct accountability for final product release. Knowledge and proven experience in FDA, EMA, or other regulatory authority. Knowledge in Operational Excellence and Continuous Improvement is desirable. Experience in building and growing an organization into a high performance team. Demonstrated leadership, interpersonal, communication, and motivation skills. Excellent writing and oral communication skills are required. Previous work responsibility, which required a high degree of attention to detail. Well practiced in exercising sound judgment in decision-making. Demonstrated multitasking and organization skills. Key Responsibilities: Establish and communicates performance objectives for Quality Assurance staff that are consistent with the businesses unit goals, Quality and Technical Operations objectives. Provide quality floor support of complex manufacturing issues Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment enhances unit performance and integration across site departments. Hires, integrates and develops high quality talent, capable of delivering against the department’s goals and objectives. Provides quality oversight of manufacturing activities on a day to day basis Provides oversight of the review and approval of changes to master batch recipe records. Performs review and approval of site procedures and documents. Provides oversight to Quality walkthroughs for shutdown and inspections readiness activities and ensures program management is in compliance with site and corporate procedures. Contributes to and supports the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products. Directly participates in internal audits or reviews as well as global health authority inspections. May include representation on inspection response and CAPA teams. Provides Quality review and approval of investigation records and CAPA, records. Application of strategic foresight to identify and implement changes to enhance long term goals of the department and drive continuous improvement. May act as delegate for QA Operations management for departmental meetings, projects and tasks. Supervises up to 8 employees overseeing quality floor support of manufacturing in a 24/7 manufacturing facility Key Core behavioral indicators for this role include: Participates in the creation of a team-based environment, promoting candor, collaboration, receptivity, clarity of purpose and goals, and high commitment to achieve business goals. Demonstrates appropriate examples of compliance behaviors and attitudes. #BMSBL #LI-Onsite 전 세계적으로 우리는 심각한 질병을 앓고있는 환자의 삶에 영향을 미치기 위해 열정적입니다. 포용적인 문화에서 우리의 개인 재능과 다양한 관점을 적용 할 수있는 권한을 부여받은 우리의 열정, 혁신, 긴급 성, 책임, 포용성 및 성실성의 공유 가치는 각 동료의 최고의 잠재력을 이끌어냅니다. Bristol Myers Squibb은 업무 환경에서 균형과 유연성의 중요성을 인식하고 있습니다. 우리는 직원들에게 직장과 개인 생활에서 목표를 추구 할 수있는 자원을 제공하는 다양한 경쟁 혜택, 서비스 및 프로그램을 제공합니다 데이터 프라이버시 링크 We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.