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: 10 days 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.