Director, Global Product Quality & Transfer (QA)

Regulatory Jobs; Waco (TX); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Health, dental, vision insurance

Paid time off

401(k) plan

Job summary

AbbVie seeks a senior Quality leader to drive end-to-end product quality across small molecule, biologics, and devices in a global supply chain.

You will build and lead a global quality assurance team, partner with TPMs, AbbVie plants, and regulatory bodies, and shape strategies for new product introductions, transfers, and post-market surveillance. Requirements include 15+ years in pharma with leadership experience and regulatory inspection exposure.

Qualifications

• Bachelor’s Degree in Life Science, Pharmacy, or Engineering required.
• 15+ years total experience in pharma/biotech with 5+ years in Manufacturing and 4+ years in QA, R&D, and/or S&T.
• Minimum of 6 years of Management and Supervision experience.
• Experience with third party external manufacturing and regulatory inspections.

Responsibilities

• Lead a quality team responsible for product transfer activities and end-to-end product quality.
• Develop global QA strategy for pharma, biologics, devices, and combination products.
• Interface with external manufacturers and internal stakeholders to ensure regulatory compliance.
• Support pre-approval inspections and engage with regulatory authorities.
• Lead audits, due diligence, and corrective action planning.

Skills

Quality leadership

Regulatory knowledge

Cross-functional collaboration

Problem solving

Education

Bachelor’s Degree in Life Science/Engineering

Graduate degree preferred

Job description

AbbVie seeks a senior Quality leader to drive end-to-end product quality across small molecule, biologics, and devices in a global supply chain.

You will build and lead a global quality assurance team, partner with TPMs, AbbVie plants, and regulatory bodies, and shape strategies for new product introductions, transfers, and post-market surveillance. Requirements include 15+ years in pharma with leadership experience and regulatory inspection exposure.