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. 

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 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 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

Leadership Qualifications

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

Sanofi's leaders are versatile learners who are comfortable with complexity and ambiguity. They are courageous decision makers who are candid and direct.

Leading the Business

• Sanofi's leaders understand and respond to the evolving business environment. They think beyond their sphere of influence to see what is not obvious and create a compelling vision and direction that inspires engagement from their people.

• Sanofi's leaders continuously look internally and externally for best practices. They challenge the status quo and encourage their people to try new approaches. They have a track record of generating successful new ideas that improve business performance.

Delivering to Customers

• Sanofi's leaders understand the patien