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Global Commissioning & Qualification Lead - Job Opportunity at Lonza

Stein, Switzerland
Full-time
Senior
Posted: August 1, 2025
On-site
CHF 120,000 - 160,000 annually (approximately USD 130,000 - 175,000), reflecting the senior leadership nature of the role, global scope of responsibilities, and Switzerland's premium compensation market for pharmaceutical professionals with specialized CQV expertise.

Benefits

Comprehensive relocation assistance package for eligible candidates and families, providing significant cost savings and transition support for international moves
Competitive compensation programs specifically designed to recognize and reward high performance, ensuring top performers are retained and motivated
Extensive lifestyle, family, and leisure benefits portfolio that addresses work-life balance needs beyond standard offerings
Access to agile career development opportunities within a global leader operating across five continents
Inclusive and ethical workplace environment that prioritizes diversity and values-based decision making

Key Responsibilities

Lead and manage a global team of Commissioning and Qualification (CQ) experts, driving strategic alignment across multiple international locations to optimize project delivery and cost efficiency
Oversee comprehensive protocol generation for complex life sciences projects, ensuring all lifecycle documentation meets stringent regulatory requirements and industry standards
Direct commissioning and qualification planning and reporting processes that are critical to regulatory compliance and project success in pharmaceutical manufacturing
Manage alignment and execution of Installation/Operational Qualification (IV/IQ) static testing across all site projects, ensuring consistency and quality in global operations
Collaborate strategically with engineering, manufacturing, quality, procurement, and regulatory affairs departments to enhance CQ activity efficiency in both cost and timeline optimization
Establish and oversee remote office operations in strategic global locations, implementing cost reduction initiatives while maintaining quality standards
Assess and qualify supplier quality department capabilities, ensuring timely delivery of proper documentation that meets pharmaceutical industry standards
Lead Commissioning, Qualification, and Validation (CQV) activities to ensure full compliance with regulatory requirements and industry standards across global operations
Partner with cross-functional teams to identify and mitigate risks associated with Capital Expenditure (CAPEX) investments, protecting organizational assets and project success

Requirements

Education

Master Degree or equivalent experience in Pharma, Engineering, or Science

Experience

Proven experience in Pharma / Engineering (GEP/GMP) with an understanding of Fill and Finish Facility Building and processes

Required Skills

Proven experience in Project Management, CQV, governance People management experience preferred Proficient in English, German is an advantage Understanding of Pharmaceutical/Bio Science "Contract Manufacturing" business and experienced in cGMP Strong leadership skills with a global interaction capability Possess financial and commercial acumen, able to link understanding to project goals, costs & scheduling, and risk Strong analytical skills for in-depth analysis of complex/large datasets, drawing conclusions and supporting decisions
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical industry is experiencing unprecedented growth in contract manufacturing services as companies seek to optimize costs and focus on core competencies, driving demand for specialized CQV expertise in global operations. This trend is particularly strong in biologics and complex drug delivery systems where regulatory compliance is critical. Digital transformation in pharmaceutical manufacturing is creating demand for professionals who can integrate traditional CQV processes with modern data analytics and risk management approaches, making roles like this increasingly strategic and valuable. Regulatory harmonization across global markets is increasing the complexity of CQV operations, requiring leaders who can navigate multiple regulatory frameworks simultaneously while maintaining efficiency and compliance standards.

Role Significance

Likely managing 15-25 direct and indirect reports across multiple global locations, including regional CQ leads, project managers, and technical specialists, with broader influence over contractor and supplier teams totaling 50+ professionals.
Senior executive level position with significant strategic impact on global operations, evidenced by responsibility for multiple international offices, cross-functional leadership, and direct influence on CAPEX investment decisions. This role represents a key leadership position within Lonza's global engineering organization.

Key Projects

Global facility commissioning projects for new pharmaceutical manufacturing sites worth tens of millions in CAPEX investment Technology transfer and validation projects for new product launches across multiple markets Regulatory compliance optimization initiatives affecting multiple manufacturing sites simultaneously Strategic cost reduction and efficiency improvement programs across global CQV operations

Success Factors

Exceptional project management capabilities combined with deep technical expertise in pharmaceutical manufacturing processes, enabling effective leadership of complex, multi-site commissioning projects with strict regulatory and timeline requirements. Strong cross-cultural leadership and communication skills essential for managing global teams and stakeholder relationships across different regulatory environments and business cultures. Financial acumen and commercial awareness to balance regulatory compliance requirements with cost optimization objectives, ensuring projects deliver both quality outcomes and business value. Risk management expertise to identify and mitigate potential compliance issues before they impact project timelines or regulatory approvals, protecting both company reputation and revenue. Change management skills to implement new processes and technologies across established global operations while maintaining continuous compliance and operational excellence.

Market Demand

High demand driven by the expanding contract manufacturing sector in life sciences, increasing regulatory complexity, and the critical nature of CQV expertise in pharmaceutical operations. The global scope and leadership requirements make qualified candidates particularly scarce.

Important Skills

Critical Skills

Project management expertise is absolutely essential given the complexity of global CQV operations involving multiple sites, regulatory frameworks, and stakeholder groups, with project failures potentially costing millions and delaying critical product launches. Leadership and people management skills are crucial for success in managing global teams across different cultures and time zones, requiring exceptional communication and motivational abilities to maintain performance standards. Regulatory and GMP knowledge forms the foundation of the role, as any compliance failures could result in regulatory sanctions, product recalls, and significant reputational damage to both Lonza and its clients. Financial and commercial acumen is critical for balancing regulatory requirements with cost optimization objectives, ensuring projects deliver value while maintaining compliance standards.

Beneficial Skills

German language skills would provide significant advantage for European operations and stakeholder management, particularly given Switzerland's multilingual business environment Digital technology and data analytics capabilities would enhance traditional CQV processes and support the industry's digital transformation initiatives M&A and business development experience would be valuable given the role's involvement in assessing supplier capabilities and potentially identifying acquisition targets Six Sigma or Lean Manufacturing certifications would support continuous improvement initiatives and cost optimization objectives across global operations

Unique Aspects

Global scope with responsibility for establishing and managing remote offices across multiple continents, offering exceptional international business development experience
Direct involvement in major CAPEX investment decisions, providing rare exposure to strategic financial planning and risk management at executive level
Leadership of both internal teams and external supplier relationships, developing comprehensive supply chain and vendor management expertise
Integration of traditional pharmaceutical manufacturing expertise with modern cost optimization and efficiency improvement methodologies
Opportunity to influence global regulatory compliance strategies across multiple markets and product categories

Career Growth

Typically 3-5 years to progress to VP level within Lonza or similar roles externally, given the strategic nature of the position and demonstrated global leadership capabilities. Executive roles may be accessible within 5-7 years with successful performance.

Potential Next Roles

Vice President of Global Engineering or Operations, overseeing broader manufacturing and engineering functions beyond CQV Chief Quality Officer or Head of Regulatory Affairs, leveraging deep compliance expertise in strategic leadership roles General Manager or Site Director positions, applying operational excellence skills to full P&L responsibility Independent consulting or executive roles with other major pharmaceutical companies seeking CQV transformation expertise

Company Overview

Lonza

Lonza is a globally recognized leader in life sciences with a strong presence in contract development and manufacturing services, operating sophisticated facilities across five continents and serving major pharmaceutical and biotechnology companies worldwide.

Top-tier position in the contract manufacturing space, competing with companies like Catalent, Thermo Fisher Scientific, and WuXi Biologics, with particular strength in complex pharmaceutical manufacturing and regulatory compliance expertise.
The Switzerland location positions this role at the heart of Lonza's European operations and global headquarters region, providing access to senior leadership and strategic decision-making processes while serving as a hub for global CQV operations.
Emphasis on scientific excellence, ethical business practices, and collaborative problem-solving, with a strong focus on employee development and career ownership, typical of leading Swiss pharmaceutical companies with global reach.
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