Interim QA Director

Project overview

An established pharmaceutical organisation is seeking an experienced Interim QA Director to support a critical sterile manufacturing operation in Tampa, Florida. This is a high-priority 12-month contract requiring an accomplished quality leader with a substantial track record leading Quality Assurance functions within regulated sterile fill-finish environments.

The successful candidate will provide strategic and operational quality leadership, ensuring ongoing compliance with FDA and global GMP requirements while supporting business-critical manufacturing activities.

Responsibilities

• Lead the site Quality Assurance function for sterile fill-finish operations.
• Provide oversight of GMP quality systems including deviations, CAPAs, change controls, investigations, and batch disposition.
• Ensure continued inspection readiness and regulatory compliance.
• Partner with manufacturing, technical operations, validation, and regulatory affairs teams.
• Drive quality improvements and support operational excellence initiatives.
• Review quality metrics and implement corrective actions where required.
• Mentor and develop quality leadership teams.
• Act as a senior quality representative during customer and regulatory inspections.
• Support risk management and decision-making relating to product quality and patient safety.

Requirements

Ideal Candidate Profile

We are seeking a seasoned Quality leader who has spent multiple years operating at QA Director level within a respected pharmaceutical or biotech organisation. The ideal candidate will possess deep sterile fill-finish expertise, strong regulatory knowledge, and experience leading quality teams through inspections, operational challenges, and business-critical quality initiatives. Candidates from major pharmaceutical manufacturers and sterile CDMOs will be particularly relevant.

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biology, or a related discipline.
• Extensive experience leading Quality Assurance within FDA-regulated pharmaceutical manufacturing.
• Deep expertise in sterile fill-finish manufacturing and aseptic processing.
• Long-term experience operating at Director level within recognised pharmaceutical, biotech, or CDMO organisations.
• Strong knowledge of cGMP, FDA regulations, ICH guidelines, and quality systems.
• Excellent stakeholder management and leadership skills.
• Ability to start quickly and commit to a 12-month contract assignment in Tampa, Florida.

Project details

• Start: date 11/2026
• Duration: 12 months
• Remote: onsite
• Location: Tampa, USA, US