Director of Quality - Greenville, United States - The International Society for Pharmaceutical Engineering Inc

Description

The Director of Quality provides direct support for all Manufacturing and Quality activities.

This position supports the Quality operations across multiple shifts to oversee all quality aspects within the plant, ensuring compliance with federal regulations for current Good Manufacturing Practices (cGMP).

This is a full-time, salaried position. Relocation assistance is available. Salary depends on experience and education.

Job Duties:
Direct the day-to-day operations of the Quality Department, providing leadership, management, and developmental opportunities
Manage internal and FDA audit processes
Review relevant Investigations, Change Controls, and CAPA's
Work with plant leadership team to drive a successful Quality culture
Providing Quality Assurance oversight in the production processes
Maintaining a Quality presence in warehouse and production areas
Support validation and qualification activities
Provide management oversight for development batches and other processes, including production auditing and documentation review
Track Quality metrics and address any negative trends
Sustain Quality Systems to ensure no critical complaints or regulatory actions
Advise internal and external stakeholders on interpretation and compliance with Regulatory Guidelines, Company Policies, and Standard Operation Procedures

Requirements:
Must have Bachelor's degree in Chemistry or a related field. MBA or Master's degree preferred.
Must have 7+ years of experience in a Quality leadership (manager/director level) role within the pharmaceutical manufacturing industry
Must have 10+ years of experience in the pharmaceutical manufacturing industry total
Must have extensive experience working in a cGMP/FDA regulated manufacturing environment
Advanced communication skills (verbal/written)
Strong leadership, management, and coaching abilities

Computer skills:
MS Office required, SAP experience is a plus
Must be authorized to work in the United States
Equal Opportunity Employer

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