Contract Mfg Compliance Specialist-Waltham-MA
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The Contract Manufacturing Compliance Specialist provides compliance and quality support for applicable GxP processes within the Quality Management System (QMS). The candidate has responsibilities supporting the following areas: (1) Supplier Management including quality agreement management and external inspection and response management, and tracking; (2) Internal Audit Program and inspection readiness (3) Product Complaint Investigation management; (4) Risk Management and (5) Metrics compilation and reporting.
- Maintain compliance requirements for established QMS processes and procedures
- Train and maintain proficiency in using electronic quality systems for managing change control, deviations, CAPA, etc.
- Complete analysis, identify issues and provide recommendations for compliance improvements; if applicable, help remediate processes and systems in accordance with company standards and regulatory requirements
- Participate on projects or assignments and ensure objectives are appropriately set and met
- Demonstrate understanding of and ability to interpret US and international GxP regulations
- Interact and coordinate with internal and/or external stakeholders
BASIC QUALIFICATIONS :
- Bachelor's degree
- 4+ years of similar experience within the Biotech/Pharmaceutical industry with 6+ industry years' preferred.
OTHER SKILLS / COMPETENCIES:
- Works effectively and cooperatively with others - Establishes and maintains good working relationships
- Attention to detail, strong verbal and written communications, effective time management, and organizational skills
- Ability to multi-task and work in a fast paced and dynamic environment
- Driven with a strong focus on goals
ABOUT Sanofi Biologics External Supply:
We manage relationships with critical Contract Development & Manufacturing Organizations as suppliers of drug substance, drug product, finished goods and manufacturing services to Sanofi Biologics, Sanofi Genzyme Business Unit and other business units. And we oversee the external network as if it were a multi-product site, effectively managed and fully integrated into Sanofi’s business systems and quality systems.
Great place to work with stellar reputation, inspirational leadership and positive track record of career evolution at Sanofi. Excellence in external supply network management (timely launches, flexible, reliable & competitive supply)
Contribute to 1/3 of Biologics industrial output for therapies of immunology, multiple sclerosis, rare disease, oncology, and rare blood disorders.
Attract internal and external talents and enable them to develop within Sanofi.
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