Director of Quality
3 weeks ago
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 opportunitiesManage internal and FDA audit processesReview relevant Investigations, Change Controls, and CAPA'sWork with plant leadership team to drive a successful Quality cultureProviding Quality Assurance oversight in the production processesMaintaining a Quality presence in warehouse and production areasSupport validation and qualification activitiesProvide management oversight for development batches and other processes, including production auditing and documentation reviewTrack Quality metrics and address any negative trendsSustain Quality Systems to ensure no critical complaints or regulatory actionsAdvise 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 industryMust have 10+ years of experience in the pharmaceutical manufacturing industry totalMust have extensive experience working in a cGMP/FDA regulated manufacturing environmentAdvanced communication skills (verbal/written)Strong leadership, management, and coaching abilitiesComputer skills: MS Office required, SAP experience is a plusMust be authorized to work in the United States
Equal Opportunity Employer
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