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Associate Director, GE Commissioning and Qualification (CQ) (80-100%) (m/w/d) - Job Opportunity at Lonza

Stein, Switzerland
Full-time
Executive
Posted: August 1, 2025
On-site
CHF 140,000 - 180,000 annually (approximately USD 155,000 - 200,000), reflecting the executive-level responsibilities, specialized pharmaceutical engineering expertise, and Swiss market premiums. The role's global scope, team leadership requirements, and critical impact on multi-million dollar CAPEX projects justify positioning in the upper quartile of pharmaceutical engineering compensation.

Benefits

Comprehensive relocation assistance package including family support for eligible international candidates, demonstrating strong investment in talent acquisition
Agile career development framework with dynamic work culture promoting professional growth and adaptability
Performance-based compensation programs with recognition systems that reward high achievers above market standards
Competitive base salary complemented by extensive lifestyle, family, and leisure benefits package
Inclusive and ethical workplace environment fostering diversity and equal opportunity advancement
Global career opportunities across five continents with cross-functional collaboration exposure

Key Responsibilities

Lead and strategically manage a global team of CQ experts, driving operational excellence across multiple international locations while building organizational capability
Oversee comprehensive protocol generation for complex life sciences projects including critical lifecycle documentation that ensures regulatory compliance and business continuity
Direct commissioning and qualification planning and reporting processes that directly impact multi-million dollar CAPEX investments and project timelines
Manage alignment and execution of IV/IQ static testing across all site projects, ensuring consistent quality standards and regulatory adherence globally
Drive cost optimization and timeline efficiency improvements across the entire CQ portfolio while supporting departmental leads and cross-functional teams
Establish and oversee strategic remote offices in key global locations to enhance operational efficiency and reduce project costs
Assess and qualify supplier quality departments' capabilities and capacity, ensuring timely delivery of critical documentation for project success
Lead comprehensive CQV activities ensuring full compliance with stringent regulatory requirements and industry standards across all jurisdictions
Collaborate with senior cross-functional teams to identify, assess, and mitigate risks associated with significant CAPEX investments and strategic projects

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 and biotechnology industries are experiencing unprecedented growth driven by personalized medicine, cell and gene therapies, and accelerated drug development timelines, creating significant demand for specialized commissioning and qualification expertise. Contract Development and Manufacturing Organizations (CDMOs) like Lonza are particularly well-positioned as pharmaceutical companies increasingly outsource manufacturing to focus on core R&D activities. Regulatory frameworks are becoming increasingly complex and stringent globally, with agencies like FDA, EMA, and other international bodies requiring more comprehensive validation and qualification documentation. This trend is driving demand for senior-level CQ professionals who can navigate multi-jurisdictional compliance requirements while maintaining operational efficiency. The industry is witnessing a significant shift toward modular and flexible manufacturing facilities, particularly for fill-and-finish operations, requiring advanced commissioning and qualification strategies that can adapt to multiple product types and regulatory requirements. This evolution demands leaders who can balance technical expertise with strategic business acumen.

Role Significance

Likely managing a global team of 15-25 CQ specialists across multiple locations, with indirect influence over 50+ professionals including suppliers, contractors, and cross-functional partners. The role involves establishing and scaling remote offices, suggesting responsibility for building teams from ground up in strategic locations.
This is a senior executive position with significant strategic impact, evidenced by global team leadership responsibilities, oversight of multiple international offices, and direct influence on major CAPEX investment decisions. The role sits at the intersection of technical expertise and business strategy, requiring both deep pharmaceutical engineering knowledge and executive-level commercial acumen.

Key Projects

Multi-million dollar greenfield and brownfield pharmaceutical facility projects including state-of-the-art fill-and-finish operations Complex technology transfer projects requiring comprehensive validation and qualification across multiple sites and regulatory jurisdictions Strategic CAPEX initiatives involving advanced manufacturing technologies and automation systems requiring sophisticated commissioning approaches Global harmonization projects standardizing CQ processes and documentation across Lonza's international network of facilities

Success Factors

Demonstrated ability to balance technical rigor with commercial pragmatism, ensuring regulatory compliance while optimizing project costs and timelines in a highly competitive CDMO environment Exceptional cross-cultural leadership capabilities enabling effective management of diverse global teams and navigation of complex stakeholder relationships across multiple time zones and regulatory environments Strategic thinking combined with operational excellence, capable of translating high-level business objectives into detailed technical execution plans while maintaining flexibility for emerging opportunities Deep understanding of pharmaceutical supply chain dynamics and contract manufacturing business models, enabling effective risk assessment and mitigation strategies for complex CAPEX investments

Market Demand

Very High - The convergence of pharmaceutical industry growth, increasing regulatory complexity, and the specialized nature of commissioning and qualification expertise creates exceptional demand for senior-level professionals. The global shortage of experienced CQ leaders, particularly those with fill-and-finish facility expertise, positions qualified candidates in an extremely favorable market.

Important Skills

Critical Skills

Advanced project management capabilities are absolutely essential given the complexity of coordinating multiple international projects simultaneously, each with distinct regulatory requirements, stakeholder groups, and technical challenges that can significantly impact business outcomes Deep pharmaceutical engineering expertise, particularly in fill-and-finish operations, is fundamental to success as these specialized manufacturing processes require sophisticated validation approaches and represent significant risk and investment for pharmaceutical companies Global leadership and cross-cultural management skills are paramount given the international scope of responsibilities and the need to build effective teams across diverse regulatory and cultural environments while maintaining consistent quality standards

Beneficial Skills

Digital transformation and Industry 4.0 knowledge would be increasingly valuable as pharmaceutical manufacturing adopts advanced automation, data analytics, and digital validation approaches that can differentiate service offerings Business development and client relationship management skills would enhance effectiveness given the CDMO business model's dependence on long-term client partnerships and the role's influence on major investment decisions Regulatory affairs expertise beyond traditional GMP, including emerging areas like cell and gene therapy regulations, would provide competitive advantage as Lonza expands into these high-growth therapeutic areas

Unique Aspects

This role uniquely combines global strategic oversight with hands-on technical leadership, offering exposure to cutting-edge pharmaceutical manufacturing technologies while building and managing international teams across multiple time zones and regulatory environments
The position provides rare opportunity to shape Lonza's global CQ strategy while establishing new international offices, offering entrepreneurial experience within a large, established organization
The role sits at the critical intersection of technical validation and commercial success, requiring navigation of complex regulatory requirements while driving cost optimization and efficiency improvements across multi-million dollar projects
Exposure to Lonza's diverse portfolio including traditional pharmaceuticals, biotechnology products, and emerging cell and gene therapies provides comprehensive industry experience rarely available in a single role

Career Growth

3-5 years to VP level positions, 5-8 years to C-suite roles, depending on business results and additional strategic experience gained. The global scope and executive responsibilities of this role provide accelerated pathway to senior leadership positions.

Potential Next Roles

Vice President of Engineering or Operations within pharmaceutical or biotechnology companies, leveraging the comprehensive technical and business experience gained in this role Chief Operating Officer positions at mid-size CDMOs or biotechnology companies, building on the strategic business acumen and operational leadership experience Independent consulting opportunities specializing in pharmaceutical facility commissioning and regulatory compliance, capitalizing on the global network and expertise developed

Company Overview

Lonza

Lonza is a globally recognized leader in life sciences with a strong presence across five continents, specializing in pharmaceutical, biotechnology, and nutrition markets. The company has established itself as a premier Contract Development and Manufacturing Organization (CDMO) with particular strength in complex pharmaceutical manufacturing, cell and gene therapy production, and specialized chemical synthesis.

Lonza holds a dominant position in the global CDMO market, particularly in high-value, complex manufacturing segments. The company is consistently ranked among the top three CDMOs globally and is particularly well-regarded for its technical expertise, regulatory compliance track record, and ability to handle complex, high-potency pharmaceutical products.
The Swiss location represents Lonza's European headquarters and a key strategic hub for pharmaceutical manufacturing operations. Switzerland's position as a global pharmaceutical center provides access to leading industry talent, regulatory expertise, and proximity to major pharmaceutical companies, making this a high-impact regional assignment.
Lonza emphasizes scientific excellence, ethical business practices, and inclusive workplace culture. The company's focus on 'talented people working together' suggests a collaborative environment that values innovation and individual contribution while maintaining rigorous quality and compliance standards typical of the pharmaceutical industry.
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