Vendor Quality & Risk Manager - GMP/GDP

Katalyst CRO; Boston (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO seeks a Vendor Quality Management Manager to proactively assess vendor risk in GMP/GDP areas and translate insights into justified oversight of third parties. The role drives tools and processes across vendor types to advance fit-for-purpose quality management.

Responsibilities include monitoring trends, mitigating vendor risk, reporting on risk, and guiding improvement efforts as a vendor quality SME.

Qualifications

• Regulatory knowledge in GMP/GDP areas.
• Experience with KPIs and vendor quality metrics.
• Expertise in risk assessment for third parties / suppliers.

Responsibilities

• Monitors metrics and dashboards for emerging trends for vendors in GMP/GDP area(s).
• Ensures adequate management and mitigation of risk arising from vendors.
• Supports processes and procedures to report on, manage, and mitigate vendor risk to acceptable levels.
• Leads and/or participates in process and system improvement efforts as a vendor quality SME.
• Provides onsite front and/or back-room inspection support as assigned.
• Provides insight on vendor risk and its potential impact in quality and business forums.

Skills

GMP/GDP regulatory knowledge

Vendor quality KPIs

Third‑party risk assessment

Interpersonal skills

Effective communication

Analytical risk assessment

Collaborative / matrixed work style

Education

Bachelor's degree in a scientific or allied health field

6+ years relevant experience

Job description

Katalyst CRO seeks a Vendor Quality Management Manager to proactively assess vendor risk in GMP/GDP areas and translate insights into justified oversight of third parties. The role drives tools and processes across vendor types to advance fit-for-purpose quality management.

Responsibilities include monitoring trends, mitigating vendor risk, reporting on risk, and guiding improvement efforts as a vendor quality SME.