Bristol-Myers Squibb Company

Manager, Global Quality Systems

New Brunswick, NJ, US
Dec 13, 2018
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
  • 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