Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But 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. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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 with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

Qualifications & Experience:

• Bachelor's degree in science, or a related field.

• 4+ years of experience in a pharmaceutical/ biopharmaceutical/Advanced Therapeutic Modality Products (ATMP) environment including previous QA experience - e.g., QA compliance role, Supplier Quality oversight. ATMP experience a plus.

• Solid understanding of quality management systems, change control processes, and GMP/GDP regulatory requirements.

• Familiarity with conducting quality assessments and implementing risk mitigation strategies.

• Knowledge of supplier management principles and practices.

• Strong attention to detail and excellent organizational skills.

• Strong written and verbal communication and interpersonal skills, with the ability to collaborate with cross-functional teams and suppliers.

• Strong decision-making capability and ability to think conceptually and understand impact of decisions.

• Ability to work independently and prioritize tasks effectively in a fast-paced environment.

• Knowledge of risk management methodologies and tools.

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

Key Responsibilities

Supplier Evaluation and Selection:

• Collaborate with cross-functional teams to identify and evaluate potential suppliers across all operating units based on quality requirements and business needs.

• Conduct supplier assessments, including and evaluations, to ensure compliance with quality standards and regulatory requirements.

• Conduct reviews and evaluations of Third Party Risk Mgmt. (TPRM) due diligence quality questionnaires for new supplier entities and follow through/remediation of issues identified in the Risk Summary Report for the Quality Risk Domain.

• Work in collaboration with the appropriate Supplier Quality and stakeholder teams to assess issues identified in the TPRM process that cannot be remediated by the supplier and determine path forward.

• Analyze supplier capabilities, performance, and risk factors to support supplier selection decisions.

Supplier Qualification and Onboarding:

• Execute supplier qualification processes and criteria to ensure suppliers meet our quality standards.

• Coordinate with suppliers to collect and review necessary documentation, such as quality agreements, certifications, and quality control plans.

• Conduct on-site visits or virtual assessments to verify supplier capabilities and quality management systems, as required.

• Own follow up and closure of supplier audit finding corrective and preventive actions (CAPAs) in electronic quality management systems.

Risk Based Oversight Processes:

• Coordinate and document the network level qualification/maintenance and documentation of Vendor & Materials Mgmt. QMS risk-based quality oversight processes for global (multi-site use) suppliers as assigned.

• Perform other duties in support of BMS Vendor & Material Mgmt. Quality System development and maintenance as assigned.

Supplier Performance Monitoring:

• Collaborate with the Supplier Quality team to establish and maintain a comprehensive supplier performance monitoring system for assessing the quality and reliability of suppliers.

• Identify opportunities for supplier improvement and collaborate with suppliers to implement corrective and preventive actions.

SOP Development and Revision:

• Collaborate with subject matter experts and cross-functional teams to develop new SOPs or revise existing ones.

• Conduct thorough research and gather information to ensure accuracy and completeness of SOP content.

• Write clear, concise, and well-structured SOPs that align with QMS requirements, regulatory requirements, and company standards.

• Ensure SOPs are easily understandable and user-friendly for employees at all levels.

• Collaborate with training and development teams to ensure effective training programs are in place for SOP implementation.

• Assist in the development of training materials and job aids to support SOP understanding and adherence.

• Communicate SOP updates and changes to relevant stakeholders and ensure proper implementation.

Compliance and Regulatory Requirements:

• Ensure that all supplier quality mgmt. practices comply with applicable regulatory requirements, industry standards, and internal quality management systems.

• Stay updated on relevant regulations and industry best practices related to supplier quality mgmt. and incorporate them into the change management process.

• Collaborate with Regulatory Affairs and Quality Assurance teams to ensure that all necessary regulatory submissions and notifications are completed for supplier quality mgmt.

Continuous Improvement:

• Drive continuous improvement initiatives related to supplier quality mgmt. processes, tools, and systems.

• Analyze data and metrics related to supplier quality mgmt. to identify trends, areas for improvement, and opportunities to enhance efficiency and effectiveness.

• Collaborate with cross-functional teams to implement process improvements and best practices for managing supplier quality management processes.

• Other project work and special assignments as assigned.

Other Responsibilities:

• Support Health Authority inspections and audits of BMS sites/functions, act as QA representative (SME) for functional area relevant topics.

• Lead/Participate as QA representative to internal work streams, projects, and improvement initiatives.

• Other responsibilities, as assigned.

#BMSBL

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R1583547

Updated: 2024-09-09 03:57:52.557 UTC

Location: Cruiserath-IE

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.