Senior Quality Leader — GMP & Regulatory Compliance

AbbVie Inc.; Illinois; Sur place; USD 150 000 - 180 000; Plein temps

Avantages offerts par ce poste

Benefits package

Résumé du poste

AbbVie Inc. seeks a Senior Manager, Quality to lead the Quality Function within Operations.

This role oversees Quality Systems implementation across QA, QC, Validation, Training, and Regulatory Compliance while guiding a budget and a team of quality professionals to ensure regulatory alignment and high efficiency. The incumbent will act as SME for AbbVie plants, drive Quality initiatives with executives, and ensure compliance with cGMP, FDA, EU, and related regulations.

Qualifications

• Bachelor’s degree in Physical or Life Sciences, Pharmacy or Engineering required; Master’s or PhD preferred.
• 8+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical, biologics, device or chemical industry.
• 4+ years of supervisory/technical leadership experience.
• Familiar with statistical quality systems, electronic document management and laboratory information management.
• Must have effective people management and communication skills and knowledge of cGMP and regulatory requirements.

Responsabilités

• Responsible for various aspects of quality assurance and quality control related to products produced at the plant.
• Represents the decision-making authority on job specific aspects of the Quality and Regulatory compliance program for the site.
• Ensures product is consistently manufactured in conformance with corporate Quality requirements and regulatory requirements.
• Manages a team of quality professionals and provides training and supervision.
• Provides regulatory and technical guidance to all plant departments and can be the SME for all AbbVie plants.
• Communicates with executive level for Quality Management Review and Quality Initiatives.
• Responsible for development and administration of the annual operating budget for the Quality Unit.
• Quality decisions related to plant operations including facility design, laboratory controls and product specifications to meet cGMP, FDA, EU, DEA and other regulatory requirements.

Connaissances

Quality Assurance

Quality Control

Quality Engineering

Regulatory Compliance

cGMP

FDA knowledge

EU regulatory requirements

Statistical quality systems

Electronic document management

Laboratory information management

People management

Communication skills

Budget management

Leadership

Formation

Bachelor’s Degree in Physical or Life Sciences, Pharmacy, or Engineering

Master’s Degree

PhD

Description du poste

AbbVie Inc. seeks a Senior Manager, Quality to lead the Quality Function within Operations.

This role oversees Quality Systems implementation across QA, QC, Validation, Training, and Regulatory Compliance while guiding a budget and a team of quality professionals to ensure regulatory alignment and high efficiency. The incumbent will act as SME for AbbVie plants, drive Quality initiatives with executives, and ensure compliance with cGMP, FDA, EU, and related regulations.