Bristol Myers Squibb Manager, Global Quality Systems in New Brunswick, New Jersey
Responsible for lifecycle management of procedural documents and supporting documents within the end-to-end GxP Quality Management System (QMS) Framework, including but not limited to document authoring, coordination of review and comments resolution, approval, issuance, training, implementation, periodic review, and retirement.
Responsible for compliance assessment of QMS Framework 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 (QUMAS).
Provide compliance oversight and serve as quality approver for documents and records owned/managed by Global Quality above-site functions.
Support strategic initiatives and continuous improvement projects related to QMS.
• Minimum of a Bachelor’s degree in science
• Minimum of 8 years of pharmaceutical industry 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.
• Excellent technical writing, project, time and inter-personal management skills.
• 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
• Demonstrates the BMS BioPharma behaviors
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.