Principal Compliance Specialist

Bioverativ Inc. Waltham, MA
JOB DESCRIPTION:

The Principal 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) Internal audit program and inspection readiness; (2) External inspection including response management and tracking; (3) Annual Product Reports for commercial products; (4) Product disposition; and (5) Metrics compilation and reporting.

RESPONSIBILITIES:

Maintain compliance requirements for established QMS processes and procedures

Provide support to product disposition process by reviewing batch related 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

QUALIFICATIONS:

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

EDUCATION:

Bachelor's degree or equivalent and 6+ years of relevant experience within the Biotech/Pharmaceutical industry. 8+ industry years preferred.

ABOUT BIOVERATIV:

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.