Associate Director, Product Quality

Scorpion Therapeutics; North Chicago (IL); On-site; USD 150,000 - 190,000; Full time

Job summary

Scorpion Therapeutics in the United States seeks a Lead Global Quality Assurance leader for pharma, biologics, and combination products, including sterile, device assets. You will ensure compliance and on-time product delivery across AbbVie and third-party sites.

The role requires extensive QA, regulatory liaison experience, and leadership to drive audits, quality systems, and continuous improvement while collaborating with R&D, manufacturing, and regulatory teams.

Qualifications

• Bachelor's in Life Sciences or related field; 10+ years in QA or regulatory roles in pharma.
• Direct experience interacting with regulatory agencies.
• Strong knowledge of pharmaceutical/biologics tech, manufacturing, and quality systems.

Responsibilities

• Oversee product transfer activities across sites.
• Develop and implement quality strategies for AbbVie and 3rd parties.
• Primary QA contact for external manufacturing.
• Support regulatory submissions and quality metrics.
• Lead audits, inspections, and quality systems development.
• Build relationships with external manufacturers, affiliates, and regulators.

Skills

QA Leadership

Regulatory Interactions

Quality Systems

Cross-functional Collaboration

Education

Bachelor's degree in Life Sciences

Tools

QMS (GxP)

Job description

Role:

Lead global Quality Assurance for pharmaceutical, biologics, and combination products, including sterile, biological, and device assets, ensuring compliance and on-time product delivery.

Responsibilities:

oversee product transfer activities, develop and implement quality strategies supporting manufacturing at AbbVie and third-party sites, act as primary QA contact for external manufacturing, support regulatory submissions, and manage quality metrics and compliance risk mitigation. Lead team activities related to audits, inspections, and quality systems development, including SOP and training implementation. Build relationships with external manufacturers, affiliates, and regulatory bodies to ensure quality standards.

Qualifications:

Bachelor's in Life Sciences or related field; 10+ years in QA, regulatory, or operations within pharma, with direct experience interacting with regulatory agencies; strong knowledge of pharmaceutical and biologics technologies, manufacturing processes, and quality systems.

Preferred:

graduate degree, plant experience, and expertise in biological/sterile products.

High-Value:

extensive experience with third-party manufacturing, regulatory inspections, and global compliance; leadership in quality systems; cross-functional collaboration with R&D, Supply Chain, and Regulatory teams.

Work setup and travel not specified.