Head, Contamination Control

Role Summary

Head, Contamination Control based in Framingham, MA. Responsible for developing and leading contamination control strategies, ensuring regulatory and quality compliance, and driving continuous improvement across manufacturing and environmental monitoring functions.

Responsibilities

• Developing and implementing comprehensive contamination control strategic programs in alignment with the organizational strategy, vision, and objectives
• Developing and implementing effective strategies and procedures for contamination control across the organization (environment, water, steam, gas, bio-cleaning, gowning, aseptic processes and practices and industrial supplies, etc.) and qualification/validation for processes (microbio strategy)
• Ensuring the compliance of products and processes with applicable contamination control regulatory requirements and company quality standards
• Maintaining a system to ensure contamination risks are properly identified, tracked and mitigated in partnership with quality risk management and site portfolio risk manager
• Overseeing production activities on the floor to ensure best practices, identify risk, drive mitigations, and educate staff
• Overseeing, with Q&V team, the validation, qualification and monitoring of methods, equipment and the environment ensuring contamination control
• Following metrics and monitoring data for contamination control activities to identify trends and implement action plans
• Promoting a culture of quality throughout the organization
• Establishing and monitoring KPIs for contamination control and microbiological activities, and reporting on performance and effectiveness
• Identifying and driving continuous improvement initiatives and projects to enhance contamination control activities
• Evaluating and recommending new technologies, tools, and methods to enhance contamination control and microbiology
• Leading and managing the contamination control team, including hiring, training, coaching, professional development and performance evaluation
• Leading complex contamination control and microbiological investigations to identify root causes and CAPA to prevent recurrence
• Interacting with external bodies and Global Quality to bring knowledge of best industry practices
• Preparing and participating in regulatory inspections and audits, providing expertise on contamination control and microbiology
• Providing support for collaboration between Digital, Quality and technical functions for new solutions in contamination control and Environmental Monitoring
• Building consensus across functional areas for contamination control improvements and sustainability

Qualifications

• Master's degree and 10+ years of experience or Bachelor's degree and 12+ years of experience
• 6+ years of experience in the Biotech / Pharmaceutical Industry
• 8+ years of leading teams, projects, or people

Preferred Qualifications

• Experience with single use technology manufacturing processes and digital systems in manufacturing
• Membership in industry organizations related to CGMP compliance with focus on microbiology and contamination control/sterility assurance
• Project leadership for new product introductions and new manufacturing plant start-up and design to ensure contamination control principles

Special Working Conditions

• Ability to gown and gain entry to controlled, classified areas