Evotec · 3 hours ago

Senior Manager, Global Quality Risk Management | Just. – Global Quality Systems - Remote

New Jersey, United States

Full-time

Remote

Senior Level, Lead/Staff

$111K/yr - $154K/yr

8+ years exp

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Responsibilities

Leads and directs all aspects of the QS related to QRM functions at Global level to assure compliance with quality and industry regulatory requirements.

As Business Process Owner (BPO) for QRM owns the Global QRM business process.

Executes risk management strategy for process characterization and process validation activities.

Collaborates with other GxP business process owners (BPOs) and Subject Matter Experts (SMEs) to review written procedures to create QRM process structure and enhance training program.

Owns the Global Risk Registry and ensures appropriate communication to Senior Leadership Team.

Ensures that the site-specific QRM process and procedures comply with the Global process.

Leads and participates in the development and deployment of QRM process tools.

Develops, communicates, and delivers training regarding process or system changes.

Supports internal and external client audits and regulatory inspections. Including but not limited to SME for QRM and related document retrieval during regulatory inspections.

Performs routine and ad hoc metric reporting and analysis for the Global and sites data related to QRM process.

Provides communication as to the status of deliverables to customers, management, and stakeholders.

Qualification

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Quality Risk ManagementBiologics Regulatory RequirementsProject ManagementEQMS DatabasesData CollectionMicrosoft Office

Required

Bachelor’s degree or equivalent in biological or engineering science with 8+ years of relevant Quality experience and 10+ years’ experience in the biotech industry.

Experience in QS specifically QRM processes, tools, concepts, and methodologies.

Critical thinker with a comprehensive understanding of biologics regulatory requirements, risk management principles, and science-based decision making.

Project management experience.

Excellent interpersonal skills to collaborate with team members globally.

Strong computer skills including Microsoft Office and eQMS databases.

Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making.