Global Director, Manufacturing QA & Compliance

ABBVIE; Waco (TX); On-site; USD 161,000 - 305,000; Full time

Job summary

AbbVie is seeking a senior quality leader to oversee product quality across small molecules, biologics, and devices. You will drive end-to-end quality, regulatory conformance, and strategic QA initiatives with internal teams and external manufacturers.

The role requires deep experience in manufacturing QA, regulatory inspections, and cross-functional leadership to ensure timely market entry and ongoing compliance across global sites.

Qualifications

• Bachelor’s degree in Life Science, Pharmacy, or Engineering required.
• Minimum 5 years in a direct Plant pharmaceutical setting and 4 years in QA, R&D, or S&T.
• Minimum 6 years of management and supervision experience.
• Experience with regulatory inspections and interactions with regulators.

Responsibilities

• Lead and develop a quality team for product transfer activities and end-to-end quality across the NPI supply chain.
• Manage relationships with Third Party Manufacturers and AbbVie plants to align quality requirements.
• Define and implement a global Product Quality Assurance strategy for pharma, biologics, devices, and combination products.
• Support legal agreements to ensure quality and regulatory compliance in product/service contracts.
• Serve as main quality liaison between TPMs and AbbVie Operations for commercial launches and product transfers.
• Coordinate audit plans, due diligence, and inspection readiness with QA and regulators.

Skills

Leadership

Quality management

Regulatory compliance

Cross-functional collaboration

Problem solving

Auditing

Strategic planning

Project management

Education

Bachelor’s degree in Life Science, Pharmacy, or Engineering

Graduate degree preferred

Job description

AbbVie is seeking a senior quality leader to oversee product quality across small molecules, biologics, and devices. You will drive end-to-end quality, regulatory conformance, and strategic QA initiatives with internal teams and external manufacturers.

The role requires deep experience in manufacturing QA, regulatory inspections, and cross-functional leadership to ensure timely market entry and ongoing compliance across global sites.