Manager, Global Quality Product Surety and Serialization

Bristol-Myers Squibb New Brunswick, NJ

About the Job

Description:

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
 
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support.  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
 
Accountable for supporting the establishment of Quality systems for the Global Supply Chain Security program including Serialization, Track-and-Trace, Anti-counterfeiting and Product Authentication and supporting their maintenance in accordance with GMPs, global health authorities’ requirements and expectations.
 
Responsibilities\:
  1. Support the design and implementation of a robust and compliant global framework of GMP policies, directives, procedures and processes for the Global Product Surety and Serialization program, including Track-and-Trace, Anti-counterfeiting and Product Authentication
  2. Support the establishment of a sustainable strategy for the Global Quality Product Surety and Serialization programs
  3. Monitor pre-defined deliverables within the scope of this position on a monthly basis and make adjustments in anticipation of changes to internal business and regulatory environment.  
  4. Maintain awareness of evolving Supply Chain Security and Serialization global regulations and trends and implement systems to address potential GMP compliance impact
  5. Communicate effectively and build cooperative and supportive working relationships with Serialization, and Corporate Security team, sites, and cross-functional groups with related responsibilities across BMS
  6. Active participation in pharmaceutical industry meetings, symposia, workshops to establish industry relationships, best practices and regulatory guidance as related to Supply Chain Security and Serialization
  7. Support the establishment and maintenance of Global Quality Product Surety and Serialization metrics
  8. Identifies and recommends appropriate actions, activities and projects for continuous improvements 
  9. Perform other duties as required

Qualification:
Education\:
Minimum of a Bachelor's degree or higher in Biological Sciences, Chemistry or related science or engineering discipline
 
Experience / Knowledge Desired\:
  • A minimum of 10 years of pharmaceutical industry experience and demonstrated leadership in Quality and/or Compliance discipline with in-depth knowledge of  global health authorities regulations and requirements
  • A minimum of 3 years experience and in-depth knowledge of GMP requirements of  Quality Assurance programs and direct experience involving Global Product Surety and Serialization, including Track-and-Trace, e-pedigree,  Anti-counterfeiting technology, and Product Authentication
  • Ability to effectively translate and communicate health authorities regulations 
  • Cross-functional experience in three or more areas (i.e. Quality Assurance, Product Surety, Manufacturing, Packaging Technology, Corporate Security, Supply Chain, Regulatory etc.) is required
  • Experience with manager level interactions and influence with Manufacturing Operations, Packaging Technology, Corporate Security,  Regulatory, and Supply Chain
  • Experience with SAP, Business Planning and Control Systems, Inventory Management, and Quality Software IT Tools
  • Experience in Pharmaceutical or BioTech Manufacturing Operations 
  • Collaborate and lead cross-functionally to help drive continuous improvement and promote knowledge sharing and endorsement of best practices across sites
  • Experience in managing cross-functional teams
  • Strong verbal and written communication skills 
  • Excellent influencing, facilitation and project management skills 
  • Subject matter expertise in regulatory requirements and expectations in Serialization, Product Surety and/or Quality Assurance is required   
  • Capability to build alignment with business partners including, commercial operations and manufacturing regional and site leaders 
  • Strong project management focus and ability to focus on execution of strategic decisions while balance conflicting priorities
  • Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives
  • Demonstrated ability to make and act on decisions while balancing speed, quality and risk
  • Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments
  • Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights