Bristol-Myers Squibb Company

Associate Director, Global Quality Serialization and Product Surety

New Brunswick, NJ, US
May 12, 2018
Required Education
Bachelors Degree
Position Type
Full time
Accountable for establishing Quality systems to support the Global Supply Chain Security program including Serialization, Track-and-Trace, Anti-counterfeiting and Product Authentication and ensuring that they are maintained in accordance with GMPs, global health authorities' requirements and expectations.


1. Design, implement, and sustain a robust and compliant framework of GMP policies, directives, procedures and processes that support the Global Supply Chain Security program, including Serialization, Track-and-Trace, Anti-counterfeiting and Product Authentication

2. Assist with establishment of a sustainable strategy for the Global Supply Chain Security program

3. Monitors each pre-defined deliverables 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 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-functionally (GMS, MS&T, and R&D) 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

7. Establish and maintains Global Quality Supply Chain Security metrics

8. Identifies and recommends appropriate actions, activities and projects for continuous improvements

9. Support global internal and supplier audit program

10. Perform other duties as required


• Minimum of a Bachelor's degree or higher in Biological Sciences, Chemistry or Engineering

• A minimum of 15 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 5 years experience and in-depth knowledge of GMP requirements of Global Supply Chain Security program, including Serialization, 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 senior 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

• Experienced in management of people and challenging self and others to continuously learn and improve

• Collaborate and lead cross-functionally to help drive continuous improvement and promote knowledge sharing and endorsement of best practices across sites

• Experience in managing teams, and in providing coaching, development and mentoring to employees

• Strong verbal and written communication skills

• Excellent influencing, facilitation and project management skills

• Subject matter expertise in regulatory requirements and expectations in Manufacturing Technology, Serialization and/or Quality Assurance is required

• Capability to build alignment with business partners including, commercial operations and manufacturing regional and site leaders

• Strong and demonstrated strategic thinking capability with 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 leadership capability with 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