Senior Manager, Global Quality Systems / QMS Document Management

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.

Senior Manager, Global Quality Systems / QMS Document Management

The QMS Document Manager is responsible for the lifecycle management of policies and global procedures for processes in the Quality Management System Framework at BMS that govern all GxP related activities including GLP, GCP, GVP, GMP and GDP. Focus areas include Management Responsibilities, Training Management, Event Management, Change and Document Management, and Quality Risk Management.

Responsibilities:

• Responsible for lifecycle management of policies and global procedures in the GxP Quality Management System (QMS) Framework, including document authoring, coordination of review and comments resolution, approval, issuance, training, implementation, periodic review, and retirement.
• Process policies and procedures in electronic document management systems; serve as SME and provide technical support for other Document Managers in the Global Product Development & Supply organization.
• Update and maintain QMS policies and procedures Portal
• Support/manage strategic initiatives and continuous improvement projects related to QMS.
• Collects and shares best practices through direct communications and communities of practice.
• Collect metrics to identify trends and take appropriate action.
• Maintain a contemporary knowledge of current industry trends, standards and methodologies as it relates to quality systems and management.

Education:

• Minimum of a Bachelor’s degree in natural science or healthcare related fields.

Experience/Skills/Knowledge:

• Minimum of 8 years of pharmaceutical industry experience with diverse quality and/or compliance discipline.
• Demonstrated knowledge in quality and/or compliance discipline with in depth knowledge of Quality Systems across different GxP areas and global health authority regulations.
• Ability to manage high volume works with competing priorities.
• Strong negotiating and influencing skills in a matrixed organization.
• Ability to identify errors and inconsistencies within and among documents.
• Critical thinking skills in analyzing and exercising judgment on complex issues, guided by a thorough understanding of quality philosophy.
• Proficient in MS Office and Collaboration applications.
• Experience with electronic documentation management systems.
• Excellent technical writing skill.
• Strong verbal and written communication skills.
• Project management skills

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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