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