Director of Quality

Director of Quality — Pharmaceutical Manufacturing

Position Type: Full-Time
Work Schedule: Onsite
Industry: Pharmaceutical Manufacturing
Function: Quality Assurance / Quality Control Leadership

Position Summary:

The Director of Quality provides strategic and operational leadership for all Quality Assurance and Quality Control activities at an FDA-regulated pharmaceutical manufacturing site. The role oversees development, implementation, and maintenance of a compliant cGMP Quality Management System supporting commercial liquid and solid dose production.

This position serves as the sites primary quality authority and regulatory representative.

Responsibilities:

• Lead site Quality Assurance and Quality Control organizations
• Maintain Quality Management System compliant with 21 CFR 210/211
• Final approval authority for batch disposition and product release
• Manage:
  • Deviations & investigations
  • CAPA programs
  • Change control
  • Complaint handling
• Support regulatory inspections and audits as lead quality representative
• Ensure ongoing inspection readiness
• Partner with Manufacturing, Technical Operations, and Executive Leadership

Qualifications:

• Bachelors degree in Life Sciences or related field (advanced degree preferred)
• 10+ years pharmaceutical manufacturing quality experience
• Prior leadership responsibility over QA and QC teams
• Strong working knowledge of FDA regulations and cGMP requirements
• Experience in commercial manufacturing environments
• Demonstrated regulatory inspection leadership

Additional Information:

• Onsite leadership role
• Reports to senior executive leadership
• Opportunity within a stable, long-standing manufacturing organization