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. Position Summary Develop and/or revise global procedural documents to support the business unit processes in the Quality Management System (QMS) process framework. Procedural management activities include, but are not limited to, working with subject-matter experts to ensure accurate document content and compliance with health authority regulations and expectations. Key Responsibilities This position is responsible for facilitating global procedural documents across areas of the QMS Framework and in association with electronic systems that support maintaining the QMS. This includes, but not limited, to document authoring, coordination of review and comments resolution, approval, issuance, implementation, periodic review, and retirement. Responsible for compliance assessment of procedural documents against evolving global health authority regulations and health authority inspection observations. Maintain a contemporary knowledge of current industry trends, standards and methodologies as it relates to quality systems and management. Support Global Product Development & Supply organization as the SME for BMS electronic document management system. Support strategic initiatives and continuous improvement projects related to QMS Synthesize feedback from SMEs/procedural document teams to identify and resolve issues in order to accurately document current and future processes Effectively manage projects, escalate issues as necessary and identify/meet key milestones Work with limited guidance to manage the development of global procedural documents and, seek input as needed Team leadership skills that contribute to meeting team goals and resolving complex issues Exercise sound judgment, using a risk-based approach, to ensure compliance with procedural document regulations, practices, and policies Collect metrics to identify trends and take appropriate action Responsible for communication of procedural document status to businesses Qualifications & Experience Education: Minimum of a Bachelor’s degree 5+ years experience in the Biopharm/Pharmaceutical industry with cross-functional experience in one or more areas (i.e. research, analytical, quality, engineering, manufacturing, regulatory CMC, or IT) Experience with demonstrated leadership in quality and/or compliance discipline with in-depth knowledge of cGMP requirements and global health authorities’ regulations Experience/Knowledge: In depth knowledge of cGMP requirements and global health authority regulations with ability to interpret, apply and implement. Strong negotiating and influencing skills in a matrixed organization. Ability to drive consensus, performance and to lead strategically. High level of competency in procedural document writing including the appropriate use of grammar, syntax and organization of ideas Demonstrated ability to work independently and mentor team members. Ability to identify, manage, and/or escalate issues and risks to timelines. Fluent in English, with proven professional working proficiency in English for reading, writing and speaking. Why You Should Apply 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. #DDHYD #HYBRID Show more Show less
