Senior QA Lead – Product Development & Compliance

Regulatory Jobs; Chicago (IL); On-site; USD 90,000 - 150,000; Full time

Benefits offered by this job

PTO (paid time off)

Medical/dental/vision insurance

401(k) plan

Job summary

AbbVie is seeking a qualified QA professional to support AbbVie’s pipeline by reviewing batch records, releasing analytical records, and ensuring clinical supplies meet global regulatory standards. You will collaborate across functions to mitigate risks and support timely, compliant delivery of materials.

The role requires managing multiple tasks, coordinating audits, and maintaining schedules while addressing batch documentation issues and driving quality improvements across manufacturing and

Qualifications

• Bachelor’s degree in life sciences (biology, chemistry, or engineering), and/or equivalent experience.
• 4+ years of industry experience in Quality Assurance, production, or testing of active pharmaceutical ingredients, drug products, drug development, or another healthcare-related field.
• Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide GMP requirements (D, EU, US).
• 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 clearly communicate the quality position and the actions necessary to resolve issues.
• Ability to identify and resolve complex problems through effective use of technical and interpersonal skills.

Responsibilities

• Review and approve batch records and release batches or analytical records. Write/ review/ approve processes/procedures and related documents.
• Lead/assist in the preparation and management of audits conducted by regulatory agencies, customers, and R&D GxP Compliance.
• Provide quality approvals in the materials management system as defined by procedures. Write, review and/or approve exception documents and product complaints (as applicable), corrective actions/preventive actions (CA/PA) and ensure they meet timeliness requirements.
• Review/approve clinical documentation and specifications, as applicable.
• Actively lead/participate on assigned project team(s) to support the product development process by using expertise to anticipate/resolve quality issues.
• Generate, analyze, and report quality metrics to management. Lead/participate with support groups in developing/prioritizing QA activity timelines.
• Actively monitor the effectiveness of processes and quality of project work with management and propose and execute quality/process improvements.
• Provide quality oversight on the manufacturing floor, as needed.

Skills

Quality mindset

Regulatory knowledge

Communication skills

Leadership & teamwork

Problem solving

Attention to detail

Education

Bachelor’s degree in life sciences or engineering

Tools

Materials management system (MMS)

GxP compliance software

Job description

AbbVie is seeking a qualified QA professional to support AbbVie’s pipeline by reviewing batch records, releasing analytical records, and ensuring clinical supplies meet global regulatory standards. You will collaborate across functions to mitigate risks and support timely, compliant delivery of materials.

The role requires managing multiple tasks, coordinating audits, and maintaining schedules while addressing batch documentation issues and driving quality improvements across manufacturing and