Principal Specialist, New Product Introduction QA

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Key Responsibilities:

• New Product Introduction (NPI) Lead QA representative for isolator filling line operations

• Responsible for QA review and approval of products, materials, and processes related to NPI

• Responsible for QA review and approval of Change Control Requests (e.g., DCCs, CCRs) to ensure the proposed changes related to isolator filling line operations are justified, supported by data and have been appropriately validated where applicable

• Interface with other quality groups within the company on product, process, and equipment topics related to the project

• Consults management for advice on complex issues; work is self-directed; confident in making decisions for minor issues

• Recognized Subject Matter Expert within the group

• Responsible for assigned Quality Workstream initiatives

• Provides guidance to other employees in interpretation of complex data

• Works with Project and Plant Operations to ensure compliance with and understanding of cGMPs, SOPs, and policies

• Responsible for conducting QA review and approval of Validation, Engineering and Quality Control protocols, procedures, test plans and summary reports related to isolator filling line operations. This responsibility includes IQ/OQ/PQ for products, methods, equipment, and facility review and approvals.

• Performs all other tasks as assigned.

Education:

• High school diploma or equivalent required

• Bachelor’s degree preferred

• 8 years of relevant work experience required, preferably in quality assurance/quality control

• An equivalent combination of education, experience and training may substitute

• Requires detailed knowledge of cGMP, OSHA, USP and EP

• Ability to critically assess project(s) and allocate resources to efficiently achieve goals

• Ability to multi-task and be flexible

• Advanced teamwork and facilitation skills

• Advanced critical reasoning and decision-making skills

• Able to interpret results and situations and articulate recommendations for resolution

• Ability to broaden technical and scientific knowledge

• Basic knowledge of fundamental scientific problems

• Ability to provide input and build relationships internally within function and with cross-functional teams

• Able to implement solutions independently

• Able to write and review reports with clarity and brevity

• Able to produce data reports with precision

• Able to prepare written communications and communicate problems to management with clarity and accuracy

• Ability to travel up to 20%

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

BMSBL

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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