Sanofi

Head of Quality Compliance

Framingham, MA

Sponsorship not specified$161k-$233kDetected 5 days ago

ComplianceProject ManagementGMPFDA RegulatoryLeadershipCommunicationProblem SolvingMentoring

About the role

With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth.
Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world.

The department manages the compliance program for the Framingham Biologics, Framingham Biosurgery and Northborough sites (e.g. Self Inspection, Dossier Compliance, External Inspections) and provides site metrics to determine site performance against Quality Metric Indicators.
Developing, implementing, and maintaining an effective compliance program
Manage and resolve any compliance issues, or allegations that arise and take appropriate corrective and preventive actions.
Identify and drive continuous improvement initiatives and projects to enhance the site compliance fostering a culture of compliance
Ability to collaborate across functions and throughout all levels.

Bachelor's degree in a science or equivalent with 10+ years of experience or Master's degree with 8+ years' experience working in a cGMP regulated industry (human pharmaceutical drug, vaccines, and/or biologics).
Broad working knowledge of cGMP and pharmaceutical regulatory requirements (21-CFR Part 11, 210&211, 600,610)
In-depth knowledge of the systems-based inspection approach to regulatory inspections.
Special Working Conditions: Ability to gown and gain entry to controlled, classified areas
Proven record in executing and delivering results.
Knowledge of Total Quality Management (TQM), ISO, Six-Sigma, etc.

Being honest and treating people with respect and courtesy.
Constantly striving to make Sanofi a great place to work, and a company respected for the quality of its people and products.
8+ years' experience managing people/projects or related experience influencing others
Experience with hosting and managing regulatory inspections (PAI, General GMP, For-Cause inspections, etc.)
Proficient in computer software programs and applications.

Proven experience of managing internal audits and hosting external regulatory inspections from health authorities, including preparation, execution, and follow-up

Establishing and maintaining effective relationships with regulators, industry associations, customers, suppliers, and other stakeholders, and representing the company in compliance-related matters

ual opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity

This listing is sourced directly from Sanofi's careers page and normalized into a canonical job model.