Associate Director, Quality Control - (Device Quality & Regulatory)

Merck•Rahway, NJ

3d•Hybrid

About The Position

The Associate Director, Quality Control within our Research and Development Division Device Quality & Regulatory is responsible for providing QA/QC oversight of the company's Device Network design verification laboratories. This role will provide quality oversight for the qualification, calibration and maintenance of analytical laboratory instruments and equipment, method validation, and associated documentation for design verification laboratories in Rahway and the Center for Packaging & Device Analytics (CPDA). Key responsibilities include: 1. Serve as quality oversight for design verification laboratories: Quality oversight for qualification, maintenance and calibration of laboratory equipment, instrumentation and test methods used to support design verification. Provides quality approval for applicable equipment validation protocols and reports, test method validation protocols and reports, change controls, deviations and CAPA. Ensures procedures used by design verification laboratories align with Good Laboratory Practices, Good Documentation Practices, and applicable regulatory requirements Provides support for internal audits and regulatory agency audits. Promotes awareness of applicable regulatory requirements and QMS requirements for design verification laboratories 2. Ensure compliance with data integrity expectations: Leads implementation of ALCOA+ principles for data generated by the design verification laboratories Supports establishment of controls for computer system administration, data archival and data retention 3. Leadership and Personnel Management: Provide strategic direction, mentorship, and development opportunities to personnel

Requirements

Bachelor of Science in relevant scientific discipline
5 or more years of experience in quality laboratory operations
Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills
Familiarity with device design verification and design control aspects
Experience supporting internal and external audits
Biological Analysis
Continuous Improvement Tools
Counterfeit Detection
Good Documentation Practices
Good Laboratory Practices (GLPs)
Identifying Customer Needs
Internal Auditing
Lab Equipment Maintenance
Laboratory Analysis
Laboratory Equipment Calibration
Laboratory Operations
Microbiological Analysis
Proper Documentation
Quality Control Management
Quality Management
Quantitative Assay
Regulatory Awareness
Regulatory Compliance
Regulatory Requirements
System Administration
Technical Transfer
Validation Protocols

Nice To Haves

Current Employees apply HERE
Current Contingent Workers apply HERE
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