Quality Systems Manager

Allergan; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

A global biopharmaceutical company in Singapore seeks a Quality System Manager/Lead responsible for ensuring adherence to regulations and managing quality metrics. The ideal candidate has over 8 years of experience in a cGMP environment, with at least 3 years in Quality Systems. Strong leadership and communication skills are essential for success in this role. This position involves overseeing quality complaints, documentation, and training systems to maintain operational excellence and compliance with industry standards.

Benefits

Equal Opportunity Employer

Comprehensive benefits package

Qualifications

• 8-10 years in a cGMP regulated environment.
• 3 years of relevant experience in Quality System.
• 5 years of people leadership experience preferred.

Responsibilities

• Lead Quality System team to ensure compliance with regulatory requirements.
• Manage Product Complaints and Recall Management.
• Drive Operational Excellence for Quality System.

Skills

cGMP knowledge

Quality system management

Leadership

Problem-solving

Communication skills

Planning and scheduling

Education

Bachelors / Masters in Sciences or Engineering

Tools

SAP

Trackwise

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

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 Site’s 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 changesis 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 resolution of issues assignedis 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html