Senior Specialist, QA Patient Operations

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.

• Management of Key Performance Indicating metrics to ensure continuous improvement.
• Follows established procedures and performs work as assigned and develops procedures as needed.
• Able to prepare written communications and communicate to cross-functional counterparts and management with clarity and accuracy.
• Review and negotiate apheresis site Quality Agreements, as required.
• Provide Quality review and approval of training materials, internal and external procedures.
• Provide Global Patient Services (GPS) general support, data configuration, SOP review and approval
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
• Collaboration with Rest of world teams in order to ensure consistent application of global procedures and processes
• Support European team for onsite product storage assessment
• Quality Operations and Systems support including deviation management, change management, complaints, CAPA, compliance guidance (issue management)
• Assist with compliance and other regulatory inspections and in developing remediation efforts and responses. Recognize opportunity for improvement, driving CAPA and/or change control.
• Provide quality assurance guidance and input regarding quality systems application and execution in support of project activities.
• Provide real-time quality event support
• Collaborate with stakeholders to ensure robust handling and chain of identity standards are maintained throughout the lifecycle of autologous cell therapies.
• Support other Quality initiatives as directed by management.

REQUIRED QUALIFICATIONS

• Bachelor’s degree in biochemistry, biology, microbiology, chemistry, engineering or closely related areas, or equivalent experience
• Strong knowledge of relevant regulations and guidance; available to act as a resource for colleagues
• Strong skills in leading, influencing, and negotiating
• Ability to work in cross functional teams.
• More than 5 years’ experience in regulated environment (cGMP/GCP/GDP) with a minimum of 3 years’ experience in quality and compliance.
• Independent decision-making capability and ability to think conceptually and understand impact of decisions.
• Strong verbal and written communication skills in English
• Strong organizational skills, including ability to follow assignments through to completion

PREFERRED QUALIFICATIONS

• Experience within the Cellular Therapeutics environment
• Experience with Commercial products
• Ability to prioritize and successfully manage complex and competing projects
• Strong written and verbal communication skills
• Detail-oriented with expertise in problem solving and solid decision-making abilities
• Ability to work in a fast-paced environment

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.