The Quality Assurance Compliance department provides strategic leadership,
direction, and oversight for the related Biosurgery Quality System and is responsible for assuring site inspection readiness in alignment with Corporate Standards, global good manufacturing practices, regulatory requirements/guidance and current industry best
practices. The department provides oversight for the identification of risk, escalation of risk, monitoring of corrective actions and audit/inspection commitments. The Quality Assurance Compliance department makes decisions and conducts activities in Quality within constraints imposed by broad company policy and government regulations.
Position Overview with Key Responsibilities
The Quality Compliance Professional :
• Schedules and conducts self-audits/inspections, which may include GxP
and/or ISO compliance evaluations, by interpreting and applying complex, exact
documentation of regulatory and corporate procedures, as well as industry best
practices and regulatory enforcement trends/actions.
• produces reports and conducts follow-up to non-compliance
• supports timely development and closure of internal and external audit
responses and CAPAs
• assists in solving compliance problems with departments. Examples include
Manufacturing, Facilities, Quality Control, R&D/MSAT and Quality Assurance.
• participates in setting corporate quality and compliance policies
• conducts training and co-ordination of compliance auditors.
• co-ordinates the review, deployment, gap analysis, and implementation
activities for the Corporate Quality Standards and Directives, Global Operating
Procedures and Practice documents, including monitoring progress with status reports and metrics.
• contributes to the Regulatory Intelligence communication process, and Global
Response Team site responses
• participates in support functions to ensure successful external agency
The Quality Compliance Professional may also participate as a member of the Specialty Care Massachusetts SMT (Supplier Management Team) providing site-level Quality oversight to Supplier Lifecycle Management by reviewing and approving:
• requests for new material and services,
• Supplier Change Notifications (SCNs),
• Supplier and Service Corrective Actions (SCARS),
• Supplier Audit Reports,
• review QTAs (Quality Technical Agreements)
• maintain and update ASL (Approved Supplier list)
· Bachelor's Degree and 7 years of experience in Quality Assurance in a GMP
· environment, or
· Master's Degree and 5 years of experience in Quality Assurance in a GMP
· Proficiency in Microsoft Office
· Participation as lead or co-lead auditor in internal/vendor audits
· Advanced knowledge in external agency regulations
· Familiarity with Trackwise or equivalent system
· Advanced experience determining compliance trends
· Experience with project management
American Society for Quality (ASQ) Certified Auditor or equivalent
• Proficiency in leading internal/vendor audits and writing audit reports
• Ability to train employees to conduct audits
• Able to work independently
• Participation in external agency inspections (i.e. FDA, EMA)
• Knowledge in external agency regulations
• Ability to advise, coach auditees
• Excellent communication skills, good presentation and influencing skills with
the ability to interact and gain the support of management
• Demonstrated experience in continuous improvement initiatives, partnering
with other departments (internal and external to the site) for enhanced
• Skilled in achieving results toward corporate, site, and departmental
Special Working Conditions
Ability to gown and gain entry to manufacturing clean room areas.
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.
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.