Senior QA & Compliance Lead - Clinical Product Development

AbbVie; North Chicago (IL); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

Paid time off

401(k) plan

Job summary

AbbVie seeks a quality-focused professional to support clinical supplies and batch disposition activities, ensuring regulatory compliance and timely delivery to patients. You will partner across functions to mitigate risks and maintain schedules.

Responsibilities include reviewing batch records, leading audits, and driving continuous quality improvements on the manufacturing floor, with strong communication and organizational skills essential.

Qualifications

• Bachelor’s degree, typically in life sciences (biology, chemistry, or engineering), and/or equivalent experience.
• 4+ years in QA, production, or testing of APIs or drug products.
• Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and GMP requirements.
• Experience coordinating and planning complex activities.
• Proven organizational skills.
• Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities.
• Effective oral and written communication skills to convey quality positions clearly.
• Ability to identify and resolve complex problems through technical and interpersonal skills.

Responsibilities

• Review and approve batch records and release batches or analytical records.
• Lead/assist in audits conducted by regulatory agencies, customers, and R&D GxP Compliance.
• Provide quality approvals in the materials management system and write/approve exception documents and CAPAs.
• Review/approve clinical documentation and specifications.
• Lead/participate on project teams to anticipate and resolve quality issues.
• Generate, analyze, and report quality metrics to management.
• Monitor effectiveness of processes and propose quality improvements.
• Provide quality oversight on the manufacturing floor as needed.

Skills

Quality Assurance

GxP Compliance

Analytical thinking

Communication

Leadership

Problem solving

Education

Bachelor’s degree in Life Sciences

Job description

AbbVie seeks a quality-focused professional to support clinical supplies and batch disposition activities, ensuring regulatory compliance and timely delivery to patients. You will partner across functions to mitigate risks and maintain schedules.

Responsibilities include reviewing batch records, leading audits, and driving continuous quality improvements on the manufacturing floor, with strong communication and organizational skills essential.