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Job Title: Sterility Assurance Lead - Contamination Control

This is an exciting opportunity for someone with a strong background in microbiology and regulatory compliance. Here are some key points:

• Support for recombinant manufacturing process: You'll be working closely with the Head of Quality to ensure the effectiveness of the Contamination Control Strategy (CCS).

• Expertise in regulations: Your knowledge of US and EU cGMP regulations will be crucial, especially during audits where you'll represent the department.

• Strategic development: You'll have a hand in shaping the strategic direction for quality and compliance processes related cGMP.

• Continuous improvement: to develop and implement strategic direction for EU cGMP related quality and compliance processes as well as actively participate in the development of strategies for on-site and global continuous improvement projects.

This role works closely with the Head of Quality and supports the recombinant manufacturing operation, focusing on microbiology and cGMP regulations. You'll help establish and monitor the Contamination Control Strategy, represent the department during audits, and develop strategic directions for EU cGMP compliance. Additionally, you'll participate in continuous improvement projects both on-site and globally.

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:

• Utilize knowledge of microbiology and cGMP regulations to assist in establishing, maintaining, and monitoring the Contamination Control Strategy (CCS).

• Represent the Pearl River organization during audits and serve as the expert in GMP regulations.

• Develop and implement strategic directions for cGMP-related quality and compliance processes.

• Actively participate in the development of strategies for on-site and global continuous improvement projects.

• Collaborate with the Sanofi network to ensure regulatory compliance and process effectiveness.

About You

• Bachelors degree in Microbiology, Engineering, or other relevant technical field plus 5 years experience

Directly relevant experience with at least two of the following aspects of contamination control (experience with additional aspects is desired):

•          pharmaceutical microbiology,

•          aseptic processing and environmental monitoring,

•          clean room design & qualification, GMP equipment design,

•          cleaning, sterilization,

•          closed and / or reusable aseptic system processing,

•          risk assessments, regulatory audits.

Preferred Qualifications:

• Knowledge of microbiological monitoring and control methodologies. Familiarity with EU Annex 1 CCS regulations. Knowledge of pharmaceutical equipment and processes, document management systems, and data trending.

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.