Sr. Director Quality Affairs

job summary:
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.

location: Shirley, New York
job type: Permanent
salary: $275,000 - 285,000 per year
work hours: 9 to 5
education: Bachelors

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:



Required:

• 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:

• 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




Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on us.fitly.work.




Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a 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).




This posting is open for thirty (30) days.