Senior Manager, Quality Systems

Regulatory Toolkit; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Health insurance

401(k)

Job summary

AbbVie is seeking a Quality Systems and Compliance Manager to oversee regulatory, quality, and corporate audits, ensuring GMP compliance and inspection readiness. You will drive the quality systems across the site, support training programs, and lead supplier quality initiatives in partnership with Global Supplier Quality.

The role requires a Bachelor’s in health science or quality, 5+ years pharma experience with 1-3 years in QA/QC management, and proven ability to ensure regulatory compliance

Qualifications

• Bachelor’s degree in health science or quality; advanced degree preferred.
• Minimum 5 years pharma experience; 1-3 years should be quality and management experience.
• Experience managing supplier quality, delivering training, ensuring compliance with external regulatory requirements, and adhering to corporate quality systems.

Responsibilities

• Oversee and manage regulatory, quality, and corporate audits and track action items to completion.
• Ensure site compliance with regulatory and current GMP requirements.
• Ensure site implements and sustains AbbVie quality systems as per policies and docs.
• Maintain inspection readiness through evaluation of compliance status of site and personnel.
• Develop and maintain an inspection management plan and SME training roadmap with refresher trainings.
• Perform GEMBA walks to identify and address quality and compliance issues.
• Author, implement, and maintain the BLI Inspection Readiness Plan.
• Ensure site meets training and compliance metrics; improve training program and guide resources.
• Manage site supplier quality program with Global Supplier Quality to ensure policy compliance.

Skills

Quality systems management

Supplier quality management

Compliance training

Regulatory compliance

Audit management

Education

Bachelor’s degree in health science or quality

Advanced degree preferred

Job description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information, visit www.abbvie.com.

Role Overview

Quality Systems and Compliance Manager with knowledge of quality systems management, supplier quality, compliance, inspection readiness, and site training, providing oversight to ensure consistently high levels of quality performance.

Responsibilities

• Oversee and manage all aspects of regulatory, quality, and corporate audits, and track resulting action items to ensure timely completion.
• Ensure site complies with all applicable regulatory and current Good Manufacturing Practice (GMP) requirements.
• Ensure site implements and sustains all aspects of the quality systems defined in AbbVie policies and operational documents.
• Maintain inspection readiness through ongoing evaluation and assessment of the compliance status site and personnel.
• Develop and maintain an inspection management plan and roadmap, including room setups, area-specific subject matter expert (SME) assignments, SME training, and periodic refresher training for audits.
• Perform periodic GEMBA walks across all areas to identify and address quality and compliance issues.
• Author, implement, and maintain the BLI Inspection Readiness Plan.
• Ensure site meets and sustains all training and compliance metrics; identify and implement improvements to the site training program, and train and guide resources in quality and training improvement techniques.
• Manage the site supplier quality program in partnership with Global Supplier Quality to ensure compliance with applicable policies and procedures.

Qualifications

• Bachelor’s Degree with related health science or quality background. Advanced degree preferred.
• Minimum 5 years pharma experience; 1-3 years should be quality and management experience.
• Experience managing supplier quality, delivering training, ensuring compliance with external regulatory requirements, and adhering to corporate quality systems.

Compensation & Benefits

• The compensation range is the range of possible base pay the Company believes in good faith it will pay for this role at the time of posting based on job grade. Individual compensation depends on many factors including geographic location.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits remains in the Company's sole and absolute discretion unless and until paid, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation: https://www.abbvie.com/join-us/reasonable-accommodations.html