Technical Manager, QA Operations, Cell Therapy

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.

Position Summary:

The Quality Assurance (QA) Manager for Continuous Improvement will be responsible for driving and assisting with continuous improvement initiatives and tech transfer projects for QA Operations. This will involve partnering with various departments, including but not limited to Quality, Manufacturing Operations, MSAT, PD, Supply Chain, and IT, to ensure compliance with all relevant quality standards and regulations throughout the product lifecycle, from product receipt to release.

The QA Manager will also be responsible for creating and providing training on batch record review activities and related controlled documents for QA during tech transfer activities. Additionally, the QA Manager will champion and take ownership of risk assessment activities, as well as CAPA and change control processes.

Knowledge, Skills and Abilities:

• Preference will be given to candidates who hold a Bachelor's degree in a related field. However, a minimum of an Associate's degree or an equivalent combination of education and experience is required
• Experience:
• 7+ years of relevant cGMP experience.  Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field is preferred.

Key Responsibilities

• Lead QA activities for tech transfer activities and continuous improvement initiaves as the Manager of QA Operations Continuous Improvement.
• Develop and deliver comprehensive, high-quality training programs for employees at all levels, including on-the-job training, standard operating procedures, batch records, work instructions, and instructor-led classes.
• Assist in project coordination, including meeting coordination, documentation, follow-up activities, compiling presentations, communicating status, and ensuring adherence to applicable project and operational budgets.
• Leads/ Participates in cross functional project teams, provides QA support to technical transfers in conjunction with relevant teams/ individuals.
• Ensures and drives deviations, CAPA, change controls, process transfers, and other business drivers are supported in a compliant manner.
• Represent and facilitate QA's involvement in Quality Risk Management program, proactively identifying and managing Quality Risks through documentation and facilitation of Risk Assessment activities.
• Identifies and mitigates risks in production, quality and supporting operations that could negatively impact the safety, identity, strength purity or quality of the product.
• Ensures QA reviews and approves documents, including standard operating procedures, batch records, material specifications, and validation protocols and reports.
• Champions a culture of exceptional teamwork, communication, and continuous improvement within the QA Operations team and across the organization.
• Ensures a culture that embraces the safety of the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements.
• Assists in the design, implementation and continuous improvement of Quality Assurance systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
• Support implementation of process improvements for inspection readiness, partner with QA Compliance for audit and inspection preparations, and respond to requests/questions during audits/inspections.
• Provides support during trouble shooting of equipment, operation, and processes as it relates to ensuring the quality and compliance of the product.
• Provides Quality input during the optimization of the use of raw materials, equipment, and personnel in producing compliant products and leads/participates in continuous improvement initiatives as part of Juno’s commitment to operational excell