Strategic Quality Systems Leader — Pharma & Devices

BioSpace; North Chicago (IL); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

PTO & Holidays

Medical/Dental/Vision Insurance

401(k)

Job summary

AbbVie in North Chicago, IL seeks a Manager Quality Systems to provide QA support across pharmaceutical, biologics, cosmetics and device products. The role translates strategy into tactical objectives to meet regulatory requirements and ensure product quality from raw material inspection through shipment.

The position oversees supplier qualification, change management, ASL governance, training programs, and audits by FDA, EMA and internal teams, with leadership of cross-functional professionals.

Qualifications

• Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or related field.
• 8+ years in quality assurance or related.
• Experience leading cross-functional teams.
• Knowledge of QA systems and GMP.
• Strong communication and collaboration skills.

Responsibilities

• Ensure quality regulations across drug, biologics, cosmetics, device and/or combination products.
• Lead cross-functional project teams for quality documentation.
• Maintain effectiveness of the quality system per policies and regulations.
• Design quality systems and processes to ensure compliance and efficiency.
• Coordinate training and audits (FDA, EMA, internal).
• Interact with internal and external partners to share best practices.
• Perform assessments to identify gaps and drive improvements.
• Oversee training programs for quality assurance.

Skills

Leadership of cross-functional teams

Quality assurance

Regulatory knowledge

Communication skills

Project management

Education

Bachelor's Degree in Chemistry/Pharmacy/Biology/Engineering

Job description

AbbVie in North Chicago, IL seeks a Manager Quality Systems to provide QA support across pharmaceutical, biologics, cosmetics and device products. The role translates strategy into tactical objectives to meet regulatory requirements and ensure product quality from raw material inspection through shipment.

The position oversees supplier qualification, change management, ASL governance, training programs, and audits by FDA, EMA and internal teams, with leadership of cross-functional professionals.