Vendor Quality Management Manager

Katalyst-Healthcares-; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst-Healthcares- is seeking a Vendor Quality Management Manager to proactively assess vendor risk within GMP/GDP areas and translate insights into tailored oversight across our third parties. The role drives process improvements and supports systems fit-for-purpose for vendor types.

This position requires a strong background in GMP/GDP regulations, risk assessment, and quality metrics, with the ability to communicate effectively and work in a matrixed environment.

Qualifications

• Strong knowledge of regulatory requirements in GMP/GDP areas.
• Demonstrated experience with KPIs and quality metrics for vendors.
• Expertise in risk assessment for third parties/suppliers.
• Strong interpersonal skills to explain difficult information and build alignment.
• Excellent written and oral communication abilities.
• Mathematical acumen and excellent analytic skills for risk assessments.
• Ability to work effectively in a matrixed, collaborative environment.

Responsibilities

• Monitors metrics and dashboards for emerging trends for vendors in GMP/GDP areas.
• Ensures adequate management and mitigation of risk arising from vendors.
• Supports processes to report on, manage, and mitigate vendor risk.
• Leads and/or participates in vendor quality process improvement efforts.
• Provides onsite front and/or back-room inspection support as assigned.
• Provides insight on vendor risk in quality and business forums.

Skills

GMP/GDP regulations

Vendor KPIs

Vendor risk assessment

Interpersonal skills

Communication skills

Analytical skills

Matrixed environment

Education

Bachelor's degree in scientific or allied health

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.

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