What are the responsibilities and job description for the Self-Inspection Manager position at Sanofi?
Job Overview / Responsibilities
Responsible for support in the Quality Systems Self-Inspection function.
The incumbent will assist the Self-Inspection team to ensure operations are performed and documented in a compliant manner.
The Self-Inspection function is in place to compliance of the operational areas of the Swiftwater site meet Sanofi standards and Regulatory requirements.
The incumbent will be accountable for ensuring a constant state of inspection readiness as it applies to GMP compliance
Accountable for participation as an audit team member, under the direction of a lead auditor, of the routine self inspections of manufacturing and support areas within Vaccines Industrial Affairs.
These self inspections are performed to ensure operations are executed in compliance with written procedures, regulations and standards.
Responsible for routine shop floor inspection readiness walkthroughs of all areas of the site to ensure continued state of inspection readiness.
Responsible for documenting audit progress, discussions and follow ups throughout the audit process and at the conclusion of the audit.
Provide the lead auditor support by managing the Self-Inspection audit events and commitments in the Phenix system.
Provide support to Global document management to ensure site compliance with Global requirements
Responsible for support of regulatory inspections as required.
The position has the potential to work up to 50% of non-audit time remotely.
Personnel in this role will develop strong organization and negotiation skills to support the remediation of identified deficiencies, oftentimes through dynamic organizational shifts.
Education Qualification
Bachelor's Degree in life sciences, engineering or related disciplines.
Preferred Qualification
A minimum 2 years experience in a cGMP controlled/pharmaceutical industry is desired.
Experience in a regulated Quality environment is desired.
Working knowledge of cGMPs and regulatory requirements is desired.
Must be able to work in a fast paced environment.
Must have the ability to communicate verbally and in written format effectively through multiple layers of the organization.
Must be an active learner and possess strong critical thinking skills.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
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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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
