Director of Quality Systems & Compliance
Location | Massachusetts |
Discipline: | Quality Assurance |
Job type: | Permanent |
Contact name: | Cloe Broad |
Contact email: | cloe.broad@rbwconsulting.com |
Contact phone: | 617-802-4167 |
Job ref: | CBMAV |
Published: | 5 months ago |
Expiry date: | 03 Apr 2025 23:59 |
Startdate: | ASAP |
Now Hiring: Director, Quality Systems & Compliance
A leading clinical-stage biotech focused on kidney diseases and immuno-nephrology is seeking a Director, QMS & Compliance to drive quality initiatives, regulatory compliance, and inspection readiness. This role will ensure alignment with global regulatory requirements and industry best practices while supporting the development of novel biologic therapies.
Key Responsibilities:
Oversee GxP training, supplier management, and audit programs
Lead inspection readiness and continuous improvement initiatives
Develop and manage quality agreements, compliance metrics, and risk assessments
Collaborate cross-functionally to enhance scalable, sustainable quality processes
Qualifications:
12+ years in Biopharma Quality/Compliance
Expertise in GxP, QA systems, and regulatory requirements
Experience with audit execution, supplier qualification, and risk management
Strong leadership in inspection readiness and compliance frameworks
Familiarity with Veeva and ComplianceWire
This is an opportunity to lead quality and compliance strategy in a fast-growing biotech environment. Apply today.
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