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 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 patient and customer viewpoint.
They build trust and collaboration by delivering exceptional service while balancing the needs of the individual with the greater good.
Sanofi's leaders set ambitious and realistic targets, drive for results and build accountability within the organization.
They set high standards and continuously improve
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The salary range for this position is:
$148,125.00 - $246,875.00All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.