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.
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.
About You:
Bachelor's degree in Sciences, Technical, Engineering or Advanced degree with 3-4 years in a cGXP manufacturing environment or a Master’s degree in Sciences, Technical, Engineering or Advanced degree and 2 years of experience in cGXP manufacturing environment.
Knowledge and understanding of Manufacturing
Knowledge of GXP regulations and guidance.
Minimum of 2 years experience with deviation management systems (e.g. Trackwise, Phenix).
Excellent critical thinking and technical writing
Excellent written and oral English language skills.
Proficient with change control requests, CAPAs and deviation quality systems
Proficient in critical thinking and technical writing
Experience leading cross functional teams and facilitating team meetings.
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 adhering to on-time delivery.
Preferred Qualifications
Bachelor’s degree in Biology, Chemistry, Biochemistry or Chemical Engineering.
Experience with project management
Experience in 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.
Special Working Conditions
Ability to gown and gain entry to manufacturing areas.
Ability to work offshift hours, seldom, to support product release
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:
$100,500.00 - $167,500.00All 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.