**Job Title:** Compliance Specialist **Location:** Cambridge, 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. Your job, as Compliance Specialist within our 68 NYA Quality Compliance Team will be to is responsible for providing quality support and guidance to manufacturing and support functions to ensure continued compliance to cGMP. 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:** + Contributing to the development and maintenance of an effective compliance program ​ + Ensuring all operations comply with relevant regulatory requirements and other international standards + Providing training and guidance to employees on compliance-related topics. + Maintaining compliance-related documentation, ensuring accuracy and completeness. + Identifying potential compliance risks and contributing to the development of strategies to mitigate them. + Supporting the investigation and reporting of compliance incidents + Managing CAPA to address compliance incidents and preventing recurrence. + Contributing to continuous improvement initiatives to enhance compliance processes and systems + Preparing and participating in internal and external audits and regulatory inspections. **Following key decisions (D,A,I)** + Support management on compliance topics (A) + Review the relevance of remediation action from findings from internal and external audits related to health-related topics (A) + Advise on improvements to compliance processes and systems (A) + Advise on risk mitigation strategies (A) + Advise on corrective actions for compliance incidents (A) + Advise on continuous improvement initiatives (A) + Coordinate quality alert and batch recall process with global team (A) **About You** **Skills and Experience** **Basic Qualifications:** + Bachelor's Degree in Science, Pharmacy or related discipline and a minimum of 5 - 7 years of experience working in a regulated GMP environment or Master’s Degree and a minimum 3 years of experience working in a regulated GMP environment. + Operations experience in one or more of the following areas: Quality Assurance, Quality Control, Regulatory Affairs, Manufacturing, Technical Support, Engineering validation. + Experience working with international regulatory authorities with demonstrated understanding of US and EU regulatory requirements + Experience in ensuring compliance with local, national, and international pharmaceutical regulations and standards. + Experience of managing internal audits and external regulatory inspections, including preparation, execution, and follow-up **Preferred Qualifications:** + Qualifications • Certified and Qualified Internal Auditor with industry experience + Demonstrated ability to lead cross functional teams + Demonstrated ability and experience with problem solving methodologies + Experience implementing digital technologies + Project management experience + Demonstrated ability to effectively manage all aspects of regulatory projects + Post Graduate Studies as appropriate to augment Primary Degree **Skills** + In-depth understanding of pharmaceutical regulations, guidelines, and standards (e.g., FDA, EMA, ICH). + Ability to analyze complex compliance issues, identify root causes, and develop effective solutions + Strong verbal and written communication skills to effectively convey compliance requirements and updates to various stakeholders. + Proficiency in managing multiple compliance projects simultaneously, ensuring timely completion and adherence to standards. + Keen attention to detail to ensure accuracy in compliance documentation, audits, and reports. **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. \#GD-SG \#LI-GZ \#LI-Onsite \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** 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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! _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. Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)