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. The ideal candidate MUST have experience working in pharmaceutical quality, Veeva (QMS), supervisor background and has been through inspection process (compliance).

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
  
  
  

Requirements

Education and Experience:

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