Senior Manager, Quality Systems

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 :

Bachelors 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 employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time