Aseptic Quality Director - External Manufacturing

BioSpace; North Chicago (IL); On-site; USD 150,000 - 210,000; Full time

Job summary

AbbVie in the United States is seeking an Associate Director of Aseptic Product Quality to lead external quality assurance for aseptic manufacturing. You will guide due diligence with TPMs/CMOs, assess operations, and promote best practices across the external network to ensure robust product quality.

You will partner with internal teams, mitigate aseptic risks, and maintain compliance with regulatory expectations. Strong leadership and communication are essential for success in this global role.

Qualifications

• Bachelor's degree in Life Science or related field; graduate degree preferred.
• Minimum 10+ years in Quality Assurance Operations, Regulatory, or related roles in pharma; direct regulatory inspection experience.
• Experience with aseptic manufacturing technologies, facilities, and controls.

Responsibilities

• Lead aseptic External & Product Quality Assurance Eye Care Global Team; develop and implement aseptic strategies.
• Conduct due diligence visits to prospective TPMs/CMOs as cross-functional member.
• Perform hands-on aseptic assessments and drive adoption of best practices across external partners.

Skills

Quality Assurance Leadership

Cross-Functional Collaboration

Aseptic Manufacturing Knowledge

Regulatory Inspection Experience

Analytical Problem Solving

Education

Bachelors in Life Science

Graduate Degree Preferred

Job description

AbbVie in the United States is seeking an Associate Director of Aseptic Product Quality to lead external quality assurance for aseptic manufacturing. You will guide due diligence with TPMs/CMOs, assess operations, and promote best practices across the external network to ensure robust product quality.

You will partner with internal teams, mitigate aseptic risks, and maintain compliance with regulatory expectations. Strong leadership and communication are essential for success in this global role.