Head, Contamination Control

Job Title: Head, Contamination Control

Location: Framingham, MA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. 

Developing and implementing comprehensive contamination control strategic programs in alignment with the organizational strategy, vision, and objectives

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• 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 of production activities through on the floor partnership and presence 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 the contamination control activities, to identify trends and issues and to implement action plan

• Promoting a culture of quality throughout the organization

• Establishing and monitoring key performance indicators (KPIs) and metrics for the contamination control and microbiological activities, and report on its performance and effectiveness

• Identifying and driving continuous improvement initiatives and projects to enhance the 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

• Lead and manage complex contamination control and microbiological investigations to identify true root cause and CAPA to prevent recurrence. 

• Interacting with external bodies & Global Quality to bring knowledge and awareness of best industry practices (CoP & CoE).

• Preparing and participating in regulatory inspections and audits, providing expertise on contamination control and microbiology.

• Providing support for the successful collaboration between Digital, Quality and technical functions to achieve desired functionality, compliance and productivity for new solutions in contamination control and Environmental Monitoring areas.

• Build consensus, across functional areas and obtain stakeholder agreement for contamination control improvements and continued sustainability

About You

Basic 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 people management experience

Preferred Qualifications

• Experience working with single use technology manufacturing processes and digital systems in manufacturing

• Membership in industry organizations relative to CGMP compliance and 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

Leadership Qualifications

• Sanofi's leaders motivate and inspire their people and build effective teams. They manage for high performance and develop others within the organizati