Sanofi Group
Senior Compliance Engineer
Sanofi Group, Northborough, Massachusetts, us, 01532
Job Title:
Senior Compliance Engineer
Location
: Framingham, MA or Northborough, 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.
The Quality Control department provides Quality Control testing support of Massachusetts Biocampus production operations. The Quality Control department makes decisions and conducts activities in Quality within constraints imposed by broad company policy and government regulations. The Quality Control department consists of the following functions:
• Chemistry
• Microbiology and Environmental Monitoring
• Biopolymers
• Raw Materials
• QC Science and Technology Support which includes analytical equipment
validation, method validation expertise, and operational technical support
• QC Compliance which includes deviation & laboratory investigation support
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:
Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
• Demonstrate strong leadership qualities and embody Sanofi's core leadership principals.
• Support Quality Control investigation, review or approval of complex deviations/investigations.
• Work closely with manufacturing, quality operations and support groups to resolve assigned deviations and laboratory investigations within agreed timelines.
• Function as technical SME for complex Quality Control investigations.
• Review and interpret technical documents related to quality control processes and systems to enable sound decision making during deviations and laboratory investigations.
• Work closely with manufacturing, quality control operations group to develop effective CAPAs to reduce deviation recurrence.
• Function as management approver in Quality Management systems as manager delegate or back-up.
• Ensure that Sanofi standards are adhered to and that associated Quality Control procedures align to regulatory expectations and standard requirements.
• Represent Quality Control during internal and external audits, as required.
• Facilitate regulatory related CAPAs and audit responses.
• Generate and present metrics at the required frequency to drive accountability and delivery of targets.
• Work closely with the SMS Team to support continuous improvement of Quality Control and other continuous improvement initiatives.
• Lead Compliance Improvement Initiatives to drive improvements in the area of deviation reduction, laboratory event reduction, etc.
• Apply and interpret Sanofi corporate standards and local procedures governing the Quality Control processes, consulting with QC management or QA as appropriate.
• Support any other tasks, as required, to support business needs.
About You
Basic Qualifications:
• Bachelor's degree in Science and a minimum of 8 years' experience working in a regulated, cGXP environment or Master's degree and a minimum of 6 years' experience working in a regulated, cGXP environment.
• Operations experience in one or more of the following areas: Quality Assurance, Quality Control, or Manufacturing Technical Support.
• Demonstrated knowledge of cGXP regulations and guidance.
• Demonstrated experience with Change Control, CAPA and deviation quality systems.
Preferred Qualifications:
• Technical experience specific to QC Chemistry and/or Raw Materials platforms
• Demonstrated experience with Chromatography
• Demonstrated experience with complex investigation and deviation management
• Experience with root cause analysis tools and GAP Identification.
• Experience determining trends and metrics in deviation management or equivalent systems.
• Knowledge of regulatory agency enforcement trends
• Experience implementing digital technologies
• Experience with LEAN tools or comparable continuous improvement systems
Special Working Conditions:
• Ability to lift 10 lbs
• Ability to gown into manufacturing suites
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)
Senior Compliance Engineer
Location
: Framingham, MA or Northborough, 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.
The Quality Control department provides Quality Control testing support of Massachusetts Biocampus production operations. The Quality Control department makes decisions and conducts activities in Quality within constraints imposed by broad company policy and government regulations. The Quality Control department consists of the following functions:
• Chemistry
• Microbiology and Environmental Monitoring
• Biopolymers
• Raw Materials
• QC Science and Technology Support which includes analytical equipment
validation, method validation expertise, and operational technical support
• QC Compliance which includes deviation & laboratory investigation support
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:
Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
• Demonstrate strong leadership qualities and embody Sanofi's core leadership principals.
• Support Quality Control investigation, review or approval of complex deviations/investigations.
• Work closely with manufacturing, quality operations and support groups to resolve assigned deviations and laboratory investigations within agreed timelines.
• Function as technical SME for complex Quality Control investigations.
• Review and interpret technical documents related to quality control processes and systems to enable sound decision making during deviations and laboratory investigations.
• Work closely with manufacturing, quality control operations group to develop effective CAPAs to reduce deviation recurrence.
• Function as management approver in Quality Management systems as manager delegate or back-up.
• Ensure that Sanofi standards are adhered to and that associated Quality Control procedures align to regulatory expectations and standard requirements.
• Represent Quality Control during internal and external audits, as required.
• Facilitate regulatory related CAPAs and audit responses.
• Generate and present metrics at the required frequency to drive accountability and delivery of targets.
• Work closely with the SMS Team to support continuous improvement of Quality Control and other continuous improvement initiatives.
• Lead Compliance Improvement Initiatives to drive improvements in the area of deviation reduction, laboratory event reduction, etc.
• Apply and interpret Sanofi corporate standards and local procedures governing the Quality Control processes, consulting with QC management or QA as appropriate.
• Support any other tasks, as required, to support business needs.
About You
Basic Qualifications:
• Bachelor's degree in Science and a minimum of 8 years' experience working in a regulated, cGXP environment or Master's degree and a minimum of 6 years' experience working in a regulated, cGXP environment.
• Operations experience in one or more of the following areas: Quality Assurance, Quality Control, or Manufacturing Technical Support.
• Demonstrated knowledge of cGXP regulations and guidance.
• Demonstrated experience with Change Control, CAPA and deviation quality systems.
Preferred Qualifications:
• Technical experience specific to QC Chemistry and/or Raw Materials platforms
• Demonstrated experience with Chromatography
• Demonstrated experience with complex investigation and deviation management
• Experience with root cause analysis tools and GAP Identification.
• Experience determining trends and metrics in deviation management or equivalent systems.
• Knowledge of regulatory agency enforcement trends
• Experience implementing digital technologies
• Experience with LEAN tools or comparable continuous improvement systems
Special Working Conditions:
• Ability to lift 10 lbs
• Ability to gown into manufacturing suites
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)