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.
Qualifications and Education Requirements
Knowledge of Science generally attained through studies resulting in a Bachelor’s Degree in a scientific or engineering discipline or its equivalent.
A minimum of 5 years experience in an environment governed by cGMPs, including at least 3 years of related experience, (e.g., equipment qualification, computer system validation, analytical equipment / method validation, or process validation).
Knowledge of cGMP and regulatory requirements for validation of equipment, computerized systems, and processes.
Proficiency in the use of computers and software applications including electronic change control systems
Demonstrated interpersonal, communication, and motivation skills.
Knowledge of applicable business systems including: SAP, LIMS, Maximo and Veeva Vault are desirable
Knowledge of manufacturing executions systems such as Syncade and distributive control systems such as DeltaV is desirable
Effective written and verbal communication skills
Internal Number: R1534910
About Bristol Myers Squibb
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.