Manager, Quality Engineering

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.