Associate Director Global Quality Serialization and Product Surety

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Accountable for establishing Quality systems to support Global Supply Chain Security program including Serialization, Anti-Counterfeiting, and Product Authentication, and ensuring they are maintained in accordance with GMPs, global health authorities' requirements and expectations.

Assist leadership to 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, Anti-Counterfeiting, and Product Authentication

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

Monitor each pre-defined deliverables on a monthly basis and make adjustments in anticipation of changes to internal business and regulatory environment

Maintain awareness of evolving Supply Chain Security regulations and trends and implement systems to address potential GMP compliance impact

Communicate effectively and build cooperative and supportive working relationships with Serialization, and Corporate Security team, sites, and cross-functional departments (GPS, MS&T, R&D) across BMS

Actively participate in pharmaceutical industry meetings, symposia, workshops to establish industry relationships, best practices, and regulatory guidance as related to Supply Chain Security

Establish and maintain the Global Quality Supply Chain Security metrics

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

Support global internal and supplier audit program

Perform other duties as required

Bachelor's degree required. Master's degree preferred.

Minimum of 8 years pharma experience with demonstrated leadership in Quality and/or Compliance discipline with in-depth knowledge of global health authorities' regulations and requirements.

Minimum of 5 years' experience and in-depth knowledge of GMP requirements of Global Supply Chain Security Program, including Serialization, e-pedigree, Anti-Counterfeiting technology, and Product Authentication.

Ability to effectively translate and communicate health authority regulations

Cross-functional experience in three or more areas (i.e. Quality Assurance, Product Surety, Manufacturing, Packaging Technology, Corporate Security, Supply Chain, Regulatory, etc.)

Skilled in consulting, influencing and interacting with Sr. Leaders and influence with Manufacturing Operations, Packaging Technology, Corporate Security, Supply Chain, and Regulatory.

Experience with SAP, Business Planning and Control Systems, Inventory Management, and Quality Software IT Tools

Experience in Pharmaceutical or BioTech Manufacturing Operations

Experience in people management and challenging self and other 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

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

Strong and demonstrated strategic thinking capability with project management focus and ability to focus on execution of strategic decisions while balancing conflicting priorities

Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives

Demonstrated leadership capability 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

Ability to manage multiple priorities and complex projects in a dynamic and ambiguous environment

Strong facilitation and presentation skills a must

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.

Company: Bristol-Myers Squibb

Req Number: R1521902_EN

Updated: 2020-03-06 00:00:00.000 UTC

Location: New Brunswick,New Jersey

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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com