Manager, QA Manufacturing Operations

Position

Manager, QA Manufacturing Operations

Location

Devens, MA

Shift

Friday, Saturday and Sunday 12 hour shift 7am to 7pm

Overview

Challenging. Meaningful. Life-changing. This role is part of Bristol Myers Squibb's QA Manufacturing Operations, supporting quality assurance across manufacturing activities, with opportunities to influence site-wide quality and regulatory readiness.

Key Responsibilities

• Establish and communicates performance objectives for Quality Assurance staff that are consistent with the business unit goals, Quality and Technical Operations objectives.
• Provide quality floor support of complex manufacturing issues.
• Define and enforce performance measures, provide developmental feedback and coaching, and foster a collaborative environment to enhance unit performance and cross-site integration.
• Hire, integrate and develop high-quality talent capable of delivering against the department\'s goals and objectives.
• Provide quality oversight of manufacturing activities on a day-to-day basis and oversight of the review and approval of minor changes to master batch recipe records.
• Perform review and approval of Quality, Manufacturing, and Material Specification SOPs and documents.
• Provide oversight to Quality walkthroughs for shutdown and inspections readiness activities and ensure program management compliance with site and corporate procedures.
• Contribute to and support the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products.
• Review, approve and provide guidance for quality master data, including updates to Drug Substance lot status in applicable quality systems.
• Directly participate in internal audits or reviews as well as global health authority inspections; may include representation on inspection response and CAPA teams.
• May provide Quality review and approval of investigation records and CAPA, records.
• Provide strategic foresight to identify and implement changes to enhance long-term goals of the department and drive continuous improvement.
• May act as delegate for QA Operations Manager for departmental meetings, projects and tasks.
• Supervise up to 6 employees overseeing quality floor support of manufacturing.
• Demonstrate core behavioral indicators for a team-based environment, promoting candor, collaboration, clarity of purpose and goals, and high commitment to business goals.
• Demonstrate compliance behaviors and attitudes.

Qualifications & Experience

Compensation & Benefits

Devens, MA – US $100,480 - $121,756. Additional incentive cash and stock opportunities may be available. Benefits vary by location and role; see the careers site for details.

On-site & Accessibility

BMS supports site-appropriate occupancy models and reasonable accommodations in recruitment. For accessibility inquiries, contact adastaffingsupport@bms.com. See the Equal Employment Opportunity statement on the Careers site.

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