Sanofi Group Quality Auditor Senior, Allston, MA in Allston, Massachusetts
Quality Auditor Senior:
The Quality Assurance Compliance department is comprised of the following functions:
Managing external inspections by regulatory agencies and Global Quality Auditing, including response management and tracking of commitments, site Internal Audit program, Quality System Champion responsibilities, Site Quality Council Governance, Quality Notification and Escalation, Site Risk Profile, Global Response Team for the site (GRT audit and Regulatory Intelligence), Supplier Management Program (Supplier Management Team and QTA), and ensuring the Quality System remains aligned with corporate standards, directives and procedures.
The Quality Assurance Compliance department provides strategic leadership, direction, and oversight for the related Allston 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.
Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
The Quality Auditor Senior schedules and conducts internal and vendor audits as well as producing reports and conducting follow-up to non-compliance issues, requiring the ability to lead and coordinate diverse audit teams.
The Quality Auditor Senior:
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.
Supports timely development and closure of internal and external audit responses and CAPAs
Assists in guiding and advising on regulatory and corporate GMP compliance topics with Manufacturing, Facilities, Quality Control, R&D/MSAT and Quality Assurance.
Participates in the development of corporate quality and compliance policies, and conduct training of site personnel.
Coordinates 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 inspections
The Quality Auditor Senior may also support 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,
Draft QTAs (Quality Technical Agreements)
Minimum Bachelor's degree AND
At least 5 years of experience in GMP industry or regulated environment AND
3 years of experience leading teams/projects.
Ability to lead and manage the internal audit lifecycle (planning, execution, reporting, managing response, follow-up on commitments/CAPA)
Participation in internal/vendor audits as SME/Co-lead/Lead
Received auditor training or certification (American Society for Quality (ASQ) Certified Auditor or equivalent)
Knowledge in external agency regulations
Experience determining compliance trends
Ability to advise, coach auditees
Proficiency in Microsoft Office
Familiarity with Trackwise or equivalent system
Experience with project management
Strong communication, initiative, collaboration skills and attention to detail.
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 inspection readiness
Skilled in achieving results toward corporate, site, and departmental objectives.
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.
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