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.
Job Responsibilities
- Provides document review and approval for facility, equipment, and utility commissioning and qualification, process validation, computer system and analytical validation documentation to ensure compliance with policies and procedures.
- Ensures that all regulatory and cGMPs compliance items related to validation are satisfied and ensures Validation Master Plan (VMP) adherence.
- Reviews and approves protocol discrepancies associated with the qualification and startup of the Devens Cell Therapy Facility and participates in resulting investigations and correction / corrective action planning.
- Supports the administration and maintenance of the site change control system, assuring consistency with establishing standards for local and global change control systems.
- Provides quality oversight for calibration and maintenance activities.
- Identifies unresolved issues/decisions related to validation documents and escalates, as appropriate.
- Demonstrates appropriate examples for compliance behaviors and attitudes.
- Meets and exceeds all safety expectations and adheres to all BMS behaviors.
- Seeks opportunities for continuous improvement.
- Assists in responding to inquiries from audits and inspections from world health authorities.
- Provides Quality oversight on Technology Transfer initiatives.
- Verifies compliance with applicable BMS Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications.
