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QA Project Manager - Job Opportunity at Lonza

Oss, Netherlands
Full-time
Mid-level
Posted: June 19, 2025
On-site
EUR 55,000 - 70,000 per year based on mid-level experience requirements, Netherlands pharmaceutical market standards, and Lonza's position as a global life sciences leader requiring specialized GMP expertise

Benefits

Opportunity to work for a global leader in life sciences with operations across five continents, providing exposure to diverse markets and international best practices
Career ownership philosophy that empowers employees to drive their professional development and take initiative in their roles
Meaningful work contributing to products and services that positively impact millions of lives globally
Collaborative environment fostering scientific innovation and problem-solving in the life sciences sector
Ethical work culture that prioritizes responsible business practices and environmental protection
Professional satisfaction derived from making meaningful contributions to global health and well-being

Key Responsibilities

Architect and maintain the comprehensive Synaffix Quality System ensuring full GMP compliance, directly impacting product safety and regulatory standing
Provide critical quality oversight for manufacturing and distribution operations, including product review and release decisions that affect market readiness
Lead strategic quality initiatives to streamline operations and enhance organizational quality functions, driving operational efficiency
Serve as the primary quality representative in cross-functional teams, facilitating collaboration between departments and ensuring quality integration across all business functions
Direct audit processes including internal assessments, customer evaluations, supplier reviews, and regulatory inspections, maintaining organizational compliance and reputation
Manage high-stakes customer communications regarding quality issues, changes, and deviations, preserving client relationships and trust
Evaluate and approve critical quality documentation including deviations, change controls, CAPAs, and investigations, ensuring regulatory compliance and risk mitigation
Author and approve GMP-compliant documentation and Standard Operating Procedures, establishing quality standards across the organization
Review and approve Master Batch Records and prepare batch release packages, ensuring product quality and regulatory compliance
Champion continuous improvement initiatives for Quality Management Systems, driving organizational excellence and competitive advantage

Requirements

Education

Bachelor's or Master's Degree in Life Sciences (e.g., chemistry, biotechnology, or a related field)

Experience

3-6 years of experience as a QA officer or Project Manager within a QA department

Required Skills

Experience in the pharmaceutical industry Broad knowledge of Quality standards (e.g., ICH Q7, EU GMP part 1) Strong analytical, problem-solving and decision-making skills Excellent communication, interpersonal and teamwork skills Attention to detail, accuracy and focus on quality Ability to work independently and manage pressure effectively Proficiency in MS Office and quality software tools
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical and biotechnology industries are experiencing unprecedented growth driven by advances in personalized medicine, gene therapy, and biologics manufacturing, creating substantial demand for quality assurance professionals who can navigate complex regulatory environments and ensure product safety in innovative therapeutic areas. Digital transformation in pharmaceutical manufacturing is revolutionizing quality management systems, with increasing adoption of cloud-based quality software, electronic batch records, and data analytics tools that require QA professionals to possess both traditional compliance knowledge and modern technological proficiency. Regulatory harmonization across global markets is intensifying, particularly with ICH guidelines and EU GMP requirements becoming more stringent, necessitating QA professionals who can manage multi-jurisdictional compliance requirements and maintain consistent quality standards across international operations.

Role Significance

Typically manages 2-4 direct reports while collaborating with cross-functional teams of 8-12 professionals across manufacturing, regulatory affairs, and business development functions
Mid-level management position with significant autonomy and decision-making authority, bridging tactical quality operations with strategic organizational objectives while managing critical compliance and customer relationship responsibilities

Key Projects

Implementation of new quality management systems and digital transformation initiatives Customer audit preparation and regulatory inspection readiness programs Product transfer and technology transfer quality oversight Deviation investigation and root cause analysis projects Continuous improvement initiatives for manufacturing quality systems

Success Factors

Deep understanding of pharmaceutical GMP regulations and their practical application in manufacturing environments, enabling effective navigation of complex compliance requirements and proactive risk management Strong project management capabilities combined with attention to detail, essential for managing multiple quality initiatives while maintaining rigorous documentation standards and meeting critical deadlines Excellent communication and relationship management skills to effectively interface with customers, regulatory bodies, and internal stakeholders while representing the organization's quality standards and maintaining professional credibility Analytical thinking and problem-solving abilities to investigate quality issues, implement corrective actions, and drive systematic improvements in quality processes and systems

Market Demand

High demand driven by pharmaceutical industry expansion, increasing regulatory complexity, and the critical nature of quality assurance in life sciences manufacturing

Important Skills

Critical Skills

GMP compliance expertise is absolutely essential as this role directly impacts product safety, regulatory approval, and market access for life-saving therapeutics, with any compliance failures potentially resulting in regulatory action, product recalls, or patient safety issues Project management capabilities are crucial for coordinating complex quality initiatives across multiple departments, managing competing priorities, and ensuring timely delivery of quality objectives while maintaining rigorous documentation and communication standards Communication skills are vital for managing customer relationships, regulatory interactions, and cross-functional collaboration, as this role serves as the primary quality interface between internal teams, external customers, and regulatory bodies

Beneficial Skills

Digital quality management system proficiency to leverage emerging technologies for improved compliance monitoring, data analytics, and process optimization Biotechnology and biologics manufacturing knowledge to support Lonza's growing portfolio of complex therapeutic products and advanced manufacturing capabilities Regulatory affairs understanding to anticipate regulatory trends and proactively address compliance requirements in evolving therapeutic areas Lean Six Sigma methodologies for driving continuous improvement initiatives and optimizing quality processes while reducing operational costs

Unique Aspects

Integration with Synaffix, a specialized antibody-drug conjugate (ADC) technology company, providing exposure to cutting-edge oncology therapeutics and advanced bioconjugation technologies that represent the future of targeted cancer therapy
Direct involvement in building and maintaining quality systems for innovative therapeutic platforms, offering unique experience in emerging biotechnology applications and regulatory pathways
Opportunity to work at the intersection of traditional pharmaceutical manufacturing and breakthrough biotechnology, providing diverse experience in both established and emerging therapeutic modalities
Role combines project management with hands-on quality assurance responsibilities, offering comprehensive experience in both strategic planning and operational execution within a high-stakes regulatory environment

Career Growth

3-5 years to senior management roles with demonstrated success in quality leadership and regulatory compliance

Potential Next Roles

Senior QA Manager or Director of Quality Assurance with expanded organizational scope and strategic responsibility Regulatory Affairs Director focusing on global compliance strategy and regulatory submissions Head of Quality for business unit or regional operations with full P&L responsibility Quality Consulting roles with pharmaceutical consulting firms or regulatory agencies

Company Overview

Lonza

Lonza is a globally recognized contract development and manufacturing organization (CDMO) specializing in pharmaceutical, biotechnology, and specialty chemical manufacturing with a strong reputation for quality and innovation in the life sciences industry.

Industry leader in pharmaceutical contract manufacturing with a dominant position in complex drug development and manufacturing services, particularly in biologics and specialty pharmaceuticals
The Netherlands location represents a strategic European hub for pharmaceutical manufacturing and distribution, providing access to both EU markets and global supply chains while maintaining proximity to major pharmaceutical companies and regulatory bodies
Science-driven organization emphasizing innovation, quality excellence, and employee empowerment with a strong commitment to ethical business practices and meaningful work that improves global health outcomes
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