Bristol-Myers Squibb - New Brunswick, NJ

posted 4 months ago

Full-time - Mid Level
New Brunswick, NJ
Chemical Manufacturing

About the position

Working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. As a Manager of Supplier Changes, you will have the opportunity to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. This role is pivotal in ensuring that supplier changes are managed effectively to maintain product quality, safety, and regulatory compliance. You will be responsible for developing, implementing, and maintaining a robust supplier change management process, collaborating with cross-functional teams to assess the impact of supplier changes, and ensuring that all changes are properly documented and approved. In addition to supplier change management, you will conduct thorough risk assessments for supplier changes, utilizing risk assessment tools to evaluate potential risks and develop mitigation strategies. You will establish and maintain effective change control processes, monitor supplier performance, and collaborate with the Supplier Quality team to identify opportunities for improvement. Your role will also involve developing and revising Standard Operating Procedures (SOPs) to ensure compliance with quality management systems and regulatory requirements. Continuous improvement initiatives will be a key focus, as you analyze data related to supplier changes to identify trends and enhance efficiency. This position requires strong analytical and problem-solving skills, excellent communication and interpersonal abilities, and a proven track record of driving change and fostering a culture of continuous improvement. You will work in a fast-paced environment, collaborating with various teams to ensure that supplier changes align with quality standards and regulatory requirements. Your contributions will play a crucial role in transforming patients' lives through science, as you help maintain the integrity of the products that Bristol Myers Squibb delivers to the market.

Responsibilities

  • Develop, implement, and maintain a robust supplier change management process to evaluate, approve, and implement supplier changes.
  • Collaborate with cross-functional teams to assess the impact of supplier changes on product quality, safety, and regulatory compliance.
  • Ensure that all supplier changes are properly documented, reviewed, and approved in accordance with established procedures.
  • Conduct thorough risk assessments for supplier changes to identify potential risks and their impact on product quality, safety, and regulatory compliance.
  • Utilize risk assessment tools and methodologies to evaluate the severity, probability, and detectability of identified risks.
  • Establish and maintain effective change control processes for supplier changes, ensuring that all changes are properly evaluated, documented, and implemented.
  • Monitor and track the progress of supplier change initiatives, ensuring that they are executed within defined timelines and budgets.
  • Collaborate with the Supplier Quality team to establish and maintain a comprehensive supplier performance monitoring system.
  • Identify opportunities for supplier improvement and collaborate with suppliers to implement corrective and preventive actions.
  • Collaborate with subject matter experts to develop new SOPs or revise existing ones, ensuring accuracy and completeness of content.

Requirements

  • Bachelor's degree in science or a related field.
  • 5+ years of experience in a pharmaceutical/biopharmaceutical/Advanced Therapeutic Modality Products (ATMP) environment, including previous QA experience.
  • Strong knowledge of quality management systems, change control processes, deviation processes, and regulatory requirements.
  • Experience in conducting risk assessments and implementing risk mitigation strategies.
  • Excellent understanding of supplier management principles and practices.
  • Strong analytical and problem-solving skills, with the ability to analyze complex data and make informed decisions.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and suppliers.
  • Proven ability to drive change and foster a culture of continuous improvement.
  • Ability to work in a fast-paced environment.
  • Certifications such as Certified Quality Manager (CQM) or Certified Supplier Quality Professional (CSQP) are a plus.

Nice-to-haves

  • ATMP experience is a plus.
  • Proficient in using quality management software and tools.
  • Veeva Quality Suite experience is a plus.

Benefits

  • Competitive salary and benefits package.
  • Opportunities for professional development and career growth.
  • Flexible work environment with a focus on work-life balance.
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