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Quality Systems Lead - Job Opportunity at BAXTER

Old Toongabbie, Australia
Full-time
Senior
Posted: April 10, 2025
On-site
AUD 150,000 - 180,000 per year based on role seniority and market conditions in Australian pharmaceutical manufacturing

Benefits

Inclusive workplace with diversity recognition
Working family support structures
Professional development opportunities
Equal opportunity employment practices
Reasonable accommodation policies

Key Responsibilities

Strategic leadership of validation team and critical systems
Project management of facility and equipment validation programs
Change control system administration and oversight
Quality systems compliance management
Team development and performance optimization
Budget and capital expenditure management
Documentation and regulatory compliance oversight

Requirements

Education

Tertiary degree in Electrical / Mechanical / Chemical Engineering or equivalent fields

Experience

Experience working in a validation team within a multinational Pharmaceutical company

Required Skills

GMP knowledge in pharmaceutical manufacturing Validation and calibration methodologies expertise Project management capabilities Statistical analysis proficiency (Minitab, Tableau, SQL) Documentation accuracy Advanced communication skills Strong negotiation abilities Team collaboration High initiative
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Sauge AI Market Intelligence

Industry Trends

Increasing regulatory scrutiny in pharmaceutical manufacturing is driving demand for sophisticated quality systems leadership Digital transformation in validation processes is creating need for hybrid technical-leadership roles Growing focus on data integrity and electronic systems validation in pharma manufacturing Rising importance of risk-based validation approaches in regulatory compliance

Role Significance

Typically manages 5-8 direct reports in validation and calibration teams with matrix responsibility across departments
Senior leadership position with direct impact on manufacturing compliance and operational excellence

Key Projects

Facility and equipment validation programs Quality systems implementation and optimization Regulatory compliance initiatives Digital transformation of validation processes Team capability development

Success Factors

Strong technical expertise combined with strategic leadership capabilities Ability to balance compliance requirements with operational efficiency Excellence in stakeholder management across multiple departments Forward-thinking approach to quality systems modernization

Market Demand

High demand with growing regulatory complexity and digital transformation initiatives in pharmaceutical manufacturing

Important Skills

Critical Skills

Validation methodology expertise - essential for maintaining manufacturing compliance Project management capabilities - critical for coordinating complex validation programs GMP knowledge - fundamental for pharmaceutical manufacturing oversight Leadership skills - crucial for team development and stakeholder management

Beneficial Skills

Digital system validation experience Risk assessment methodology knowledge Change management expertise Statistical analysis capabilities

Unique Aspects

Direct impact on patient safety through quality system leadership
Combination of technical expertise and strategic management
Global company with local manufacturing presence
Strong focus on professional development and career progression

Career Growth

2-4 years in role before progression, depending on business needs and performance

Potential Next Roles

Quality Director Manufacturing Site Quality Head Global Validation Lead Technical Operations Director

Company Overview

BAXTER

Baxter is a global healthcare leader with 85+ years of innovation in medical products and therapies

Leading position in hospital supplies and clinical therapies with worldwide presence
Significant ANZ operations with strategic manufacturing capabilities
Mission-driven organization with strong focus on patient impact and professional development
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