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.
Establish and implement the global document strategy to support the business unit processes in the Quality Management System (QMS) process framework ‘Operations Controls’ for GMP/GDP. Activities include, but are not limited to: mapping the existing documents from heritage BMS and heritage Celgene organizations against the new QMS framework, collaborate with GPOs and subject-matter experts at the various manufacturing and distribution sites, ensure the document strategy is complete and accurate, and maintain compliance with health authority regulations and expectations.
This position is responsible for implementing the global procedural document strategy within operational controls including: Qualification & Validation, Facilities Design & Maintenance, Vendor & Materials Management, Production & Disposition, and Product Distribution.
Responsible for ensuring the mapping process of existing procedural documents within the Operational Controls of QMS process framework is complete and accurate.
This includes, but not limited, setting priorities based on health authority commitments, compliance gaps, risk assessments, and periodic review schedules.
Assign document ownership, timelines, document managers and other resources necessary to adhere to schedule.
Responsible for lifecycle management of procedural documents within the Operational Controls of QMS process framework, as needed.
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
Proactively use judgment to manage risk and uncertainty, and to anticipate the need for and implement contingency plans
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
Evaluate and share best practices through direct communications and communities of practice
Analyze metrics to identify trends and take appropriate action
Responsible for communication of procedural document status to businesses
Minimum of a Bachelor’s degree
8+ 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
In depth knowledge of cGMP requirements and global health authority regulations with ability to interpret, apply and implement.
Demonstrated ability to successfully manage competing deadlines and balance priorities while meeting or exceeding expectations
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
Ability to build teams, foster partnerships across multidisciplinary teams and to resolve complex issues and differences in a creative, constructive and diplomatic manner
Demonstrated ability to work independently and mentor team members
Ability to identify, manage, and/or escalate issues and risks to timelines
Excellent technical writing skills.
Proficient in MS Office and Collaboration applications.
Experience with electronic documentation management systems.
Critical thinking skills in analyzing and exercising judgment on complex issues, guided by a thorough understanding of quality philosophy.
Strong verbal and written communication skills
Project management concepts, strategies and skills
Proven ability to understand complex processes/problems and propose alternate solutions to implement global procedures requires critical thinking and analysis skills
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.