Head of Quality Assurance

We are seeking an accomplished Quality executive with extensive experience in sterile injectable pharmaceutical manufacturing to lead all Quality functions for our FDA-regulated manufacturing operations. This role is responsible for establishing and maintaining a world-class Quality organization that ensures compliance, drives operational excellence, and supports business growth.

Essential Responsibilities

Executive Leadership

• Develop and execute the company's quality strategy in support of business objectives.
• Serve as the executive leader responsible for all Quality functions across the organization.
• Build a high-performance quality culture focused on compliance, operational excellence, and continuous improvement.
• Advise executive leadership on quality risks, regulatory strategy, and compliance initiatives.

Quality Systems & Compliance

• Lead the Quality Management System, including deviations, investigations, CAPAs, change controls, complaints, recalls, document management, training, supplier quality, and management review.
• Ensure the organization maintains a constant state of FDA inspection readiness.
• Drive quality metrics and continuous improvement initiatives across the business.

Sterile Manufacturing Quality Oversight

• Provide quality oversight of all sterile manufacturing operations, including:
• Aseptic processing
• Environmental monitoring
• Media fills
• Sterility assurance
• Contamination control strategy
• Personnel qualification
• Facility and utility monitoring
• Ensure all operations meet FDA expectations for sterile drug manufacturing.

Quality Assurance & Batch Release

• Provide final approval for batch disposition and commercial product release.
• Review and approve investigations, deviations, validation protocols, reports, and quality risk assessments.
• Ensure timely resolution of quality events while maintaining product quality and patient safety.

Quality Control & Laboratory Operations

• Direct QC laboratories responsible for chemical, microbiological, and stability testing.
• Oversee OOS, OOT, and laboratory investigations.
• Ensure laboratory compliance with GMP and data integrity requirements.

Validation & Engineering Support

• Provide Quality oversight for qualification and validation activities, including:
• Process Validation
• Cleaning Validation
• Equipment Qualification (IQ/OQ/PQ)
• Computer System Validation
• HVAC Systems
• Water for Injection (WFI)
• Clean Steam
• Compressed Gases

Regulatory Leadership

• Lead FDA, customer, and international regulatory inspections.
• Prepare executive responses to FDA observations and Warning Letters when applicable.
• Monitor evolving global regulations and implement proactive compliance strategies.

Cross-Functional Partnership

• Partner with Manufacturing, Engineering, Regulatory Affairs, Technical Services, Supply Chain, and Operations to support product launches, technology transfers, and process improvements.
• Act as the Quality representative on executive leadership initiatives.

Talent Development

• Recruit, mentor, and develop Quality leaders.
• Build organizational capability through succession planning and professional development.

Required Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, Engineering, or a related scientific discipline.
• Advanced degree preferred.
• 10 years of progressive pharmaceutical manufacturing experience.
• 10 years of Quality leadership within sterile injectable manufacturing.
• Extensive experience leading Quality organizations in FDA-regulated sterile injectable facilities is required.
• Demonstrated success leading FDA inspections with favorable outcomes.
• Strong working knowledge of aseptic processing, contamination control, sterility assurance, and Annex 1 principles.

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