Quality Systems ManagerLead

The Quality System Manager/Lead is responsible to:

• Lead and manage the Quality System team to ensure site adherence to AbbVie Policies and current Good manufacturing practices (cGMP) requirements per regulatory standards.
• Responsible for Product Complaints and Recall Management Quality Metrics and Quality Management Review and Quality Plan Management and assuring the Sites Documentation Management System Training system Supplier Quality Qualification System and Deviation management system to support Quality and Operational purposes.

Major Responsibilities

People Leadership

• Lead and manage the Quality System team to ensure site quality system including Product Complaints and Recall Management Quality Metrics and Quality Management Review Quality Plan Supplier Quality System Training Management system and Documentation Control System are in compliance with regulatory requirements
• Ensure timely escalation of quality issues/ adverse events to quality management team to ensure corrective/preventive action is undertaken where required.

Compliance

• Responsible for Product Complaints and Recall Management Quality Metrics and Quality Management Review and Quality Plan Management.
• Responsible for Supplier Quality Management including Supplier Qualification Supplier Audit Supplier Performance Monitoring and Risk control Management of Quality Technical Agreement and Approved Supplier life cycle management to support operational needs.
• Responsible for Documentation Management System activities including document change management archival/retrieval controlled document issuance and GMP third party record management.  
• Responsible for establishment administration and maintenance of the site Training Program including development of training methodology framework in collaboration with functional areas managers subject matter experts and global AbbVie Training Center of Excellence monitoring of  training system effectiveness and efficiency.
• Ensure compliance with applicable AbbVie policies processes and procedures and regulatory requirements contributing to the development of site quality strategies and oversight of quality plans/programs.

Operational Excellence- Project/New Product Introduction

• Drive Operational Excellence for efficient and effective Quality System to ensure timely execution to support the high throughput multi-products plants with 24/7 operations while maintaining customer satisfaction service level
• System Ownership for Trackwise for SQA and CAPA module and collaborate with global for system enhancement.
• Responsible for Quality System (Supply Qualification Training and Documentation) related initiatives to support site/global projects such as New Product Introduction and other improvement projects and business challenges in supply chain continuity e.g. material shortage due to supply chain disruption. Collaborate with internal and external stakeholders to ensure material readiness for operational need.

Financial Acumen

• Financial needs planning for Quality System budget and ensures spend is within latest best estimates.

Qualifications :

Education

• Bachelors / Masters in Sciences (i.e. Biologicals Biomedical Chemistry Life Sciences Pharmaceutical) Pharmacy or Engineering (i.e. Biomedical Chemical Pharmaceutical) or equivalent.

Essential Skills Experience and Competencies (includes Licenses Credentials)

• A minimum of 8-10 years in a cGMP regulated environment is required.
• A minimum of 3 years of relevant experience in Quality System is required.
• People leadership experience of at least 5 years is preferred.
• Good knowledge of quality/compliance management as well as regulations and standards affecting small molecule API or Biologics manufacturing is required.
• Good working proficiency in SAP Trackwise is required.
• Proven problem-solving skills and the ability to adapt to changes is required
• Strong communication skills both verbal and written are required
• Strong presentation skills are required 
• Strong interpersonal and stakeholder management skills are required
• Good planning and scheduling skills are required
• High level of tenacity to ensure resolution of issues assigned is required

Additional Information :

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