Qlty Assurance Methods
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.
- Provide Quality oversight of routine operations at CMOs in support of cell therapy (CAR-T) intermediate product manufacturing.
- Partner with CMO Quality to provide oversight of manufacturing operations and ensure work is performed in accordance with approved regulatory submissions, master service and/or quality agreements and applicable regulatory requirements.
- Responsible for batch record review for intermediate disposition
- Responsible for review and approval of CMO deviation investigations, CAPA, controlled documents (Master Batch Records)
- Act as QA impact assessor and reviewer/approver of CMO related changes
- Support in data auditing and review of protocol/reports in support of regulatory submissions
- Develop and review/approve annual product review reports generated by CMOs
- Collaborate with Global Quality Systems and ensure CMO’s timely implementation of corrective actions resulted from BMS’s audits
- Partner with stakeholders across different operational functions to define projects in order to improve processes and represent the quality organization in implementation phase
- Drive, lead and oversee quality related improvement projects in collaboration with affected CMO functions
- Support in setting and follow up of CMO related key performance indicators (KPI) and metrics
- Provide Quality oversight of routine operations for distribution center responsible for disposition and distribution of finished cell therapy product (CAR-T) in Japan
- Partner and provide support to the Responsible Person for Quality Assurance of commercial product (Hinseki) with respect to finished drug product release for Japan
- Master’s degree or bachelor’s degree in biochemistry, biology, microbiology, chemistry, engineering, pharmacy or closely related areas.
- More than 5 years’ experience in regulated environment (cGMP/GCP/GCTP) with a minimum of 3 years’ experience in quality assurance.
- Strong organizational skills, including ability to follow assignments through to completion.
- Advanced skills in leading, influencing, and negotiating in order to manage CMOs appropriately.
- Advanced knowledge of relevant regulations and guidance; available to act as a resource for colleagues.
- Independent decision-making capability and ability to think conceptually and understand impact of decisions.
- Flexibility in responding to change or business needs
- Advanced verbal and written communication skills in Japanese and English.
- Ability to work in cross functional teams
- Experience within the Cellular Therapeutics environment.
- Experience with Commercial products.
- Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition.
- Ability to prioritize and successfully manage complex and competing projects.
- 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.