Sr. Director Quality Affairs

About the role

Step into a high-impact executive leadership role with a premier global pharmaceutical manufacturer in Shirley, NY. We are seeking a Sr. Director Quality Affairs to provide strategic leadership across site-wide compliance, laboratory operations, and quality management systems. Operating on-site in a cGMP environment, this role offers an outstanding platform to direct regulatory agency interactions and champion continuous quality improvement across all phases of production.

Responsibilities

• Provide leadership for site Quality Management Systems, including Dev, CAPA, Change Control, Document Control, and batch release oversight.
• Lead all regulatory authority inspections (e.g., FDA, Health Canada) and manage post-inspection improvement plans.
• Direct Quality Control laboratories (Stability, Chemistry, Microbiology, EM) and shop-floor manufacturing oversight.
• Partner cross-functionally with Production, Engineering, and R&D to implement new technologies and process improvements.
• Drive site-wide metrics, KPIs, and continuous quality culture across commercial and R&D products.

Qualifications

• Bachelor's degree in Life Sciences or a related field.
• Minimum 15 years of progressive pharmaceutical operations experience with direct regulatory agency interactions.
• Minimum 10 years leading functional QA, QC, compliance, or manufacturing operations.
• Proven history of direct FDA inspection interaction and hands-on shop-floor cGMP leadership.

Preferred qualifications

• Master's degree in Life Sciences.
• Experience in sterile injectables manufacturing and packaging operations.

Skills

• Good Manufacturing Practices (GMP)
• Quality Assurance (QA)
• Sterile Manufacturing
• Regulatory Audit Preparation

Pay

$275,000 - 285,000 per year

Schedule

9 to 5

Benefits

Comprehensive benefits package including medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).