Job Title: Senior Compliance Engineer
Location: Framingham, 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 ofMassachusetts Biocampus production operations. The Quality Control department makes decisions and conducts activities in Quality within constraints imposed by broad company policy andgovernment regulations. The Quality Control department consists of the followingfunctions:
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• 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 changeover 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 resolveassigned 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 andsystems to enable sound decision making during deviations and laboratory investigations.
- Work closely with manufacturing, quality control operations group to develop effectiveCAPAs to reduce deviation recurrence.
- Function as management approver in Quality Management systems asmanager delegate or back-up.
- Ensure that Sanofi standards are adhered to and that associated Quality Controlprocedures 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 anddelivery 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 theQuality 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 aregulated, 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 Microbiology/Environmental Monitoring platforms
- 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 equivalentsystems.
- Knowledge of regulatory agency enforcement trends
- Experience implementing digital technologies
- Experience with LEAN tools or comparable continuous improvement systems
- Auditor qualification
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.
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