Compliance Specialist at Sanofi Aventis US LLC

Framingham, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Jun, 26

Salary

145166.66

Posted On

21 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Compliance, GXP Manufacturing Processes, Investigation Management, Change Controls, CAPAs, Deviation Intake, Root Cause Analysis, Corrective and Preventative Action, Continuous Improvement, Process Improvement, Metrics Reporting, Analytical Ability, Teamwork, Technical Writing, Project Management, Troubleshooting

Industry

Pharmaceutical Manufacturing

Description

Job Title: Compliance Specialist Location: Framingham, MA About the Job: Compliance Specialist uses expert knowledge of compliance and GXP manufacturing processes to manage investigation and improvement initiatives within Engineering & Maintenance operations. Engineering & Maintenance Compliance Team is responsible for managing change controls, CAPAs and deviation intake and closure across GMP activities in the following areas - Metrology, Engineering, Facilities, Utilities, Validation, Automation and Capital Projects. The responsibilities of the team primarily extend to owning deviations relating to facilities, equipment and utilities and their associated systems. The Senior Compliance Specialist is responsible for developing programs and metrics to ensure all aspects of engineering and maintenance are compliant. 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: Practices and promotes safe work habits and adheres to Sanofi’s safety procedures and guidelines. Manages cross functional team to drive complex investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action. Utilizes process knowledge and investigation skill sets to identify and resolve issues, improve process operations and affect positive change. Leads cross-functional continuous improvement initiatives with Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, and Manufacturing Technical Services. Works independently with minimal supervision and direction. Participates in determining objectives of assignment. Performs work that consistently requires independent decision making and the exercise of independent judgement and discretion. Effectively utilizes Microsoft office applications. Creates and presents trending and metrics reports. Understands concepts and applications of specialized or functional area, uses independent thought, analytical ability to achieve objectives that can impact the performance of standard resources that have been allocated through a plan or a budget. Compiles facts and diagnostics from a broad variety of sources (other functions/ internal stakeholders, customers, suppliers, regulators ...) to monitor the level of satisfaction or compliance associated with the delivery of products or services. Coordinates with others via teamwork and may provide technical or behavioral expertise and guidance to deliver results. Awareness of objectives of other functions and reacts quickly to recommend and promote efficient solutions or alternatives of complex issues. Basic Qualifications: Bachelor's degree in Sciences, Technical, Engineering, Biology, Chemistry, Biochemistry, Chemical Engineering or related fields with 3 years in a cGXP manufacturing environment. OR Advanced degree in Sciences, Technical, Engineering, Biology, Chemistry, Biochemistry, Chemical Engineering or related fields with experience s in a cGXP manufacturing environment. Preferred Qualifications Experience with deviation management systems (e.g. Trackwise, Phenix). Knowledge and understanding of Manufacturing and GXP regulations and guidance. Excellent critical thinking and technical writing skills. Excellent written and oral English language skills. Proficient with change control requests, CAPAs and deviation quality systems. Experience leading cross functional teams and facilitating team meetings with ability to influence in a cross-functional environment. Proficient in balancing the speed of delivering work with quality and shows commitment to make improvements in both aspects. Effectively tracks tasks related to deviations, CAPAs, or CCRs to ensure on-time adherence and delivers results on time. Ability to work independently with minimal supervision to problem solve efficiently. Experience with project management, troubleshooting, investigation and root cause analysis in a GXP environment. Operations experience in one or more of the following areas: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Automation. Ability to gown and gain entry to manufacturing areas. 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. #GD-SG #LI-GZ #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 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: $100,500.00 - $145,166.66 All 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. Global Terms & Conditions and Data Privacy Statement 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 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

Responsibilities

The specialist manages investigation and improvement initiatives within Engineering & Maintenance operations, focusing on change controls, CAPAs, and deviation management across GMP activities. This includes leading cross-functional teams to drive complex investigation close-outs, determine root causes, and implement corrective and preventative actions.