Bioverativ Inc. Waltham , MA 02154
The (Sr/ Associate, Quality) Compliance Specialist provides compliance and quality support for applicable GxP processes within the Quality Management System (QMS). The candidate is involved in the review and disposition of Bioverativ products manufactured at Contract Development & Manufacturing Organizations (CDMOs).
Maintain compliance requirements for established QMS processes and procedures
Provide support to product disposition process by reviewing completed batch documentation and verifying GxP and Bioverativ requirements are met
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
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
Bachelor's degree or equivalent and 2+ years of relevant experience within the Biotech/Pharmaceutical industry
Bioverativ, a Sanofi company, is a global biotechnology company dedicated to transforming the lives of people with hemophilia and other rare blood disorders through world-class research, development and commercialization of innovative therapies. Launched in 2017 as an independent company spun out of Biogen's hemophilia business, we build upon a strong heritage of scientific innovation and are committed to actively working with the rare blood disorders community. The company's mission is to create progress for patients where they need it most and its hemophilia therapies when launched represented the first major advancements in hemophilia treatment in more than two decades. For more information, visit www.bioverativ.com or follow @bioverativ on Twitter.
We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. VEVRAA Federal Contractor
We Request Priority Protected Veteran and Disabled Referrals for all our locations.
Bioverativ is an E-Verify Employer in the United States.