Vendor Quality Management Manager

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

Job Profile Summary

The Vendor Quality Management Manager proactively assesses vendor risk in GMP/GDP areas and translates this assessment into insights, recommendations, and actions that allow The Company to demonstrate appropriate and tailored oversight of our third parties. The role contributes to advancement of processes, tools, and systems that are fit-for-purpose across GMP/GDP areas and vendor types.

Summary

Job Profile Summary

The Vendor Quality Management Manager proactively assesses vendor risk in GMP/GDP areas and translates this assessment into insights, recommendations, and actions that allow The Company to demonstrate appropriate and tailored oversight of our third parties. The role contributes to advancement of processes, tools, and systems that are fit-for-purpose across GMP/GDP areas and vendor types.

Responsibilities

Key Duties and Responsibilities

• Monitors metrics and dashboards for emerging trends for vendors in assigned 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

Knowledge and Skills

• Strong knowledge of regulatory requirements in GMP/GDP areas
• Demonstrated experience with key performance indicators and quality metrics for vendors
• Expertise in risk assessment as it pertains to third parties / suppliers
• Strong interpersonal skills to explain difficult information and work to build alignment
• Demonstrated ability to communicate effectively, both orally and in writing
• Mathematical acumen and excellent analytic skills as applied to risk assessments
• Demonstrated ability to work well in a matrixed, collaborative environment.

Education and Experience

• Bachelor's degree in a scientific or allied health field (or comparable degree)
• Typically requires 6 years of relevant experience, or equivalent combination of education and experience