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Là où les miracles
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Job Title: Compliance Specialist

• Location:  Swiftwater, PA

About the Job

The compliance specialist will support regulatory compliance for marketed products by means of compliant and timely handling of quality compliance and regulatory related activities at Swiftwater. The incumbent manages internal audits, regulatory compliance exercises, and regulatory activities linked to the site.

About Sanofi:

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.

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

• Monitor compliance with product registrations, laws, regulations, standards, and guidelines.

About You

Basic Qualifications

• Bachelor's Degree in Life Sciences, Engineering or technical related field

• 3+ years of experience in ensuring compliance with local, national, and international pharmaceutical regulations and standards

• In-depth Experience and understanding of pharmaceutical regulations, guidelines, and standards (e.g., FDA, EMA, ICH)

Technical Skills:

• Ability to analyze complex compliance issues, identify root causes, and develop effective solutions.

• Proficiency in managing multiple compliance projects simultaneously, ensuring timely completion and adherence to standards.

• CAPA (Corrective and Preventive Actions)

• Risk Assessment & Mitigation

• Regulatory Documentation & Reporting

• Preferred - Experience in managing internal audits and external regulatory inspections, including preparation, execution, and follow-up

Soft Skills:

• Strong verbal and written communication skills to effectively convey compliance requirements and updates to various stakeholders

• Keen attention to detail to ensure accuracy in compliance documentation, audits, and reports.

• Problem-Solving & Root Cause Analysis

• Adaptability & Continuous Learning

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.

• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.

• Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale

• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

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.

Toujours Progresser. Découvrir l’Extraordinaire.

Rejoignez Sanofi et entrez dans une nouvelle ère de la science – où votre parcours peut être aussi transformateur que le travail que nous accomplissons. Nous investissons en vous pour que vous alliez plus loin, accélériez votre réflexion et accomplissiez ce qui n’a jamais été fait auparavant. Vous contribuerez à repousser les limites, à bousculer les conventions et à concevoir des solutions plus intelligentes pour les communautés que nous servons. Prêt·e à poursuivre les miracles de la science et à améliorer la vie des gens ? Poursuivons le progrès et découvrons l’extraordinaire – ensemble.

Chez Sanofi, nous croyons dans l’égalité des chances, sans distinction de race, de couleur, d’ascendance, de religion, de sexe, d’origine, d’orientation sexuelle, d’âge, de citoyenneté, d’état civil, de handicap, d’identité de genre ou de tout autre critère protégé par la loi.