Senior Manager, Quality Systems

Allergan; Irvine, Northern (CA, KY); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Job summary

AbbVie seeks a Quality Systems and Compliance Manager to oversee regulatory, quality, and corporate audits, ensuring GMP compliance and sustained quality systems. The role requires driving inspection readiness and improving training programs to uphold AbbVie's quality standards across the site.

The successful candidate will manage supplier quality in partnership with Global Supplier Quality, develop inspection plans, and lead continuous improvements in training and compliance metrics.

Qualifications

• Bachelor’s Degree in related health science or quality background.
• Advanced degree preferred.
• Minimum 5 years pharma experience; 1-3 years should be quality and management experience.

Responsibilities

• Oversee and manage all regulatory, quality, and corporate audits and track action items.
• Ensure site complies with regulatory and current GMP requirements.
• Ensure site implements and sustains AbbVie quality systems and policies.
• Maintain inspection readiness through ongoing evaluation of compliance status.
• Develop and maintain an inspection management plan and SME training programs.
• Perform GEMBA walks to identify and address quality and compliance issues.

Skills

Quality systems management

Supplier quality

Compliance

Inspection readiness

Site training

Education

Bachelor’s Degree in health science or quality

Advanced degree preferred

Job description

Company Description

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 about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

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.
• Advance degree preferred.
• Minimum 5 years pharma experience; 1-3 years should be quality and management experience

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• 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 that are allocable to a particular employer remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, 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, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html