Bio/ Sterile Quality Strategic Quality & OE Project Manager

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.

Education and requirements:

• BS in Natural Sciences (Chemistry, Pharmacy, Microbiology, Biology), Engineering or any Science related pharmaceutical

• Ten (10) years of progressive managerial experience within a pharmaceutical/health care industry and regulatory agencies

• Five (5) years of experience in quality assurance function

• Working knowledge (implementation knowledge preferred) of Quality Assurance, Laboratory Operations, Laboratory Information

• Systems, Documentation, and /or Training Processes

• Lean Six Sigma Yellow/Green Belt required

• Deep understanding of worldwide health authority regulations to influence compliance by the adherence to risk management tools across project scope and project completion

• Process Improvement experience w/ process engineering or validation experience

• Proficient in Project Management skills

• Experience working with Senior Management

• Proficient in cGMP’s and FDA / EMA regulations and requirements.

• Experience in containment technologies

Duties and Responsibilities:

• Serve as project coordinator for key projects scoping Biologic Sterile Quality Operation Unit, GPS and the broader BMS enterprise. This includes:

• Managing logistics related to project timeline

• Supporting development of meeting materials and PowerPoint presentations

• Generating/collecting project-related data and organizing effectively to enable analysis by project team

• Identify reporting needs and generate project-related metric and trend reports on a periodic basis to support team (i.e., Quality Council, Bio/Sterile Staff meetings, etc.)

• Proactively monitor project timeline to assist coordination of activities that help prepare project team to achieve key milestones

• Maintaining and reconciling project budget and expenses

• Prioritizes and aligns Strategic Projects based upon impact to Strategic goals and objectives.

• Develops cost/benefit analysis for Quality improvement projects using critical to customer requirements.

• Manages the change from Current State to To-Be Value Streams and provides direction.

• Leads process and/or waste reduction initiatives including those in connection with system implementations (SmartLab, LIMS, etc.)

• Performs as the Bio/Sterile Operations liaison for Strategic and OE projects.

• Enables operational excellence toolset to measure impact pre- and post-implementation

• Leads structured process when solving problems: identifying problems, measuring magnitude and trend, analyzing root causes, and developing solutions that correct root causes.

• Puts systems in place to ensure solutions that are implemented continue to deliver.

• Collaborates with other PMO/Quality and OE practitioners from Bio/Sterile Sites within the GBQ network and, participates as needed in Kaizen events and other OPEX initiatives in the Biologics network.

• Develops routine, integrated messages on the Bio/Sterile Strategic projects, Quality Plan, Quality Operations OpEx program, highlight results/business benefits delivered from OPEX projects

• Engages with the Bio/Sterile Site Strategic Projects organization to drive risk management elements through the project management lifecycle ensuring cGMP and BMS policies and directives standards for final QA approval up to project completion.

• Identifies and receives requests from the Executive leadership, Functional Quality Heads and GBQ network to identify opportunities for improvement and waste reduction within Quality systems/process.

• Manages and participates during Quality Budget / Quality Capital Projects development processes for Bio/Sterile Quality Operation Unit.

BMSBL #LI-Onsite

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.

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

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