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

MSD • Rahway, NJ

2d • 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

Responsibilities

• 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
• 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
• Leadership and Personnel Management: Provide strategic direction, mentorship, and development opportunities to personnel

Benefits

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits.
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
• More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees