Senior Manager - Global Quality Risk Management

2 days ago

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Evotec

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CNS • Oncology • Pain • Neurosciences • Inflammation

5001 - 10000

Description

• Leads and directs all aspects of the QS related to QRM functions • Assures compliance with quality and industry regulatory requirements • Owns the Global QRM business process • Executes risk management strategy for process characterization and validation • Collaborates with other GxP business process owners and SMEs • Owns the Global Risk Registry and communicates with Senior Leadership Team • Ensures compliance of site-specific QRM process and procedures • Develops and deploys QRM process tools • Delivers training regarding process or system changes • Supports internal and external client audits and regulatory inspections • Performs routine and ad hoc metric reporting and analysis

Requirements

• Bachelor’s degree or equivalent in biological or engineering science • 8+ years of relevant Quality experience • 10+ years of experience in the biotech industry • Experience in QS specifically QRM processes, tools, concepts, and methodologies • Critical thinking with understanding of biologics regulatory requirements • Project management experience • Excellent interpersonal skills to collaborate with team members globally • Strong computer skills including Microsoft Office and eQMS databases • Key competencies in communication; attention to detail; data collection, management, and analysis

Benefits

• discretionary annual bonus • comprehensive benefits to include Medical, Dental and Vision • short-term and long-term disability • company paid basic life insurance • 401k company match • flexible work • generous paid time off and paid holiday • wellness and transportation benefits