Director, Quality Assurance

The Director, Quality Assurance serves as the senior site Quality leader responsible for building, leading, and maintaining a robust Quality Assurance function that supports sterile injectable manufacturing operations across both pre-commercial readiness and commercial production. This role provides strategic and operational oversight of the Pharmaceutical Quality System to ensure compliance with FDA regulations, cGMP requirements, internal procedures, and company quality standards. The Director, Quality Assurance is responsible for driving inspection readiness, ensuring independent quality oversight of site operations, and leading quality decision-making related to batch disposition, investigations, CAPAs, change control, validation support, and overall compliance performance.

Key Responsibilities:

• Lead the site Quality Assurance function and ensure effective oversight of quality systems supporting sterile injectable manufacturing operations.
• Establish, implement, and continuously improve a compliant and sustainable Pharmaceutical Quality System that supports both pre-commercial activities and routine commercial manufacturing.
• Provide Quality Assurance oversight for deviations, investigations, CAPAs, change control, document control, training compliance, batch record review, and product disposition activities.
• Ensure quality support for commissioning, qualification, validation, aseptic process simulation, technical transfer, process validation, and commercial launch readiness initiatives.
• Serve as the senior Quality representative for regulatory inspections, customer audits, and other external quality or compliance interactions.
• Partner cross-functionally with Manufacturing, Quality Control, Validation, Engineering, Regulatory Affairs, and Supply Chain while maintaining Quality’s independent authority and decision-making responsibility.
• Lead, develop, and mentor Quality Assurance personnel while promoting a culture of compliance, data integrity, accountability, and continuous improvement.

What We’re Looking For

Experience:

• Minimum of 12 years of progressive experience in Quality Assurance, Quality Systems, or related GMP quality roles within the pharmaceutical industry.
• Minimum of 5 years of leadership experience with direct management responsibility in a regulated pharmaceutical manufacturing environment.
• Minimum of 5 years of experience supporting sterile injectable, aseptic processing, or other sterile pharmaceutical manufacturing operations.
• Demonstrated experience supporting or leading quality activities related to facility start-up, validation, technical transfer, commercial readiness, and/or routine commercial manufacturing.
• Demonstrated experience with regulatory inspections, customer audits, batch disposition, investigations, CAPA, and change control oversight in a cGMP-regulated environment.
• Prior experience serving in a senior site Quality leadership capacity strongly preferred.

Education:

• Bachelor’s degree in Pharmacy, Chemistry, Microbiology, Biology, Biochemistry, Chemical Engineering, Biomedical Engineering, or a related scientific or technical discipline required.
• Master’s degree in a relevant scientific, technical, quality, or business discipline preferred.

Skills & Knowledge:

• Strong knowledge of FDA regulations, cGMP requirements, and pharmaceutical quality systems.
• Strong understanding of sterile injectable manufacturing, aseptic processing, contamination control, and cleanroom quality oversight.
• Demonstrated ability to lead investigations, assess compliance risk, and make sound quality decisions in a regulated manufacturing environment.
• Strong understanding of validation and lifecycle quality oversight, including equipment qualification, process validation, and aseptic process simulation.
• Excellent leadership, communication, and organizational skills, with the ability to effectively interact with senior leadership, regulatory inspectors, and cross-functional teams.
• Proficiency with electronic quality systems, document management systems, and standard business software platforms.

What We Offer

• Competitive compensation with annual performance bonus eligibility
• Annual merit-based pay increases
• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
• Paid Time Off
• 10 paid company holidays
• Comprehensive medical, dental, vision, and life insurance coverage
• Professional development reimbursement
• Career growth opportunities
• Tuition reimbursement for children and childcare expense reimbursement

Schedule

• Full-time, on-site position (Monday–Friday, 8:00 AM – 5:00 PM)