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Technical Quality Assurance Manager & CSV Expert - Job Opportunity at Genedata

Basel, Switzerland
Full-time
Senior
Posted: July 21, 2025
On-site
CHF 120,000 - CHF 160,000 per year (approximately USD 130,000 - USD 175,000), reflecting the specialized nature of life sciences QA expertise combined with regulatory compliance knowledge in the Swiss market, which typically offers premium compensation for technical roles in the pharmaceutical and biotechnology sectors.

Benefits

Opportunity to work with cutting-edge life sciences software solutions that directly impact scientific advancement and regulatory compliance
Professional development support through continual professional development (CPD) programs to strengthen expertise and develop competencies as an impactful Quality Professional
Exposure to global markets and diverse customer base providing international experience and cross-cultural collaboration opportunities
Access to comprehensive regulatory training and compliance expertise development in GxP, 21 CFR Part 11, GAMP5, and GDPR
Career advancement opportunities within a winning team environment focused on accelerating real-life impact of science and technology

Key Responsibilities

Lead comprehensive QA strategy and execution across the Genedata Expressionist Business Unit, directly impacting product quality standards and regulatory compliance outcomes that determine market success
Drive continuous improvement initiatives for Quality Management System processes, establishing operational excellence frameworks that enhance product quality metrics and organizational efficiency
Define and maintain critical software requirements and documentation architecture ensuring full regulatory compliance with GxP, FDA 21 CFR Part 11, ISO standards, positioning the organization for successful audits and market access
Establish end-to-end traceability systems from requirements through implementation and testing to support validation and audit readiness, creating robust documentation frameworks that support business scalability
Orchestrate cross-functional collaboration initiatives across Product Management, Development, DevOps, and Support teams to embed quality excellence throughout the complete software development lifecycle
Deliver high-value software validation services to customers in regulated environments, including comprehensive documentation, test protocols, and audit support that directly contribute to customer success and retention
Serve as the organization's primary subject matter expert on software validation and compliance in both internal strategic planning and customer-facing contexts, establishing thought leadership in the market
Support pre-sales and post-sales teams in translating complex user requirements into compliant, validated software solutions, directly contributing to revenue generation and customer satisfaction metrics
Develop and deliver comprehensive training programs on compliance topics for internal teams, building organizational capability and reducing compliance risks across the enterprise
Lead and coordinate internal, customer, and regulatory audit processes, ensuring successful outcomes that maintain business continuity and market credibility

Requirements

Education

Bachelor's or master's degree in computer science, bioinformatics, or a degree in life sciences with a strong affinity for software/computerized systems validation

Experience

5+ years in software QA, ideally in life sciences software industries

Required Skills

Strong understanding of GxP, FDA 21 CFR Part 11, ISO 9001, and GAMP5 Experience with audit preparation and compliance documentation Hands-on experience with software features that support compliance, including electronic records/signatures, audit trails, traceability, and documentation workflows Proven ability to deliver software validation services to customers, including system lifecycle documentation, test protocols, and audit support Skilled in working with product, development, DevOps, and support teams to embed quality throughout the SDLC Capable of training teams on compliance topics and representing QA in customer and regulatory interactions Strong analytical mindset with the ability to manage risks, resolve issues, and drive continuous improvement Active CPD to strengthen areas of expertise and develop competencies as an impactful Quality Professional
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Sauge AI Market Intelligence

Industry Trends

The life sciences software industry is experiencing unprecedented growth driven by digital transformation initiatives, with regulatory compliance becoming increasingly complex as organizations navigate evolving FDA guidelines and international standards. The integration of artificial intelligence and machine learning into life sciences workflows is creating new validation challenges that require sophisticated QA approaches and deep regulatory expertise. Computerized Systems Validation (CSV) expertise is becoming a critical differentiator in the life sciences market, as pharmaceutical and biotechnology companies face mounting pressure to demonstrate compliance with 21 CFR Part 11 and GxP requirements while accelerating time-to-market for critical therapies and treatments. The shift toward cloud-based life sciences platforms and Software as a Service (SaaS) solutions is creating new paradigms for quality assurance, requiring QA professionals to understand hybrid validation approaches that encompass both traditional on-premise systems and modern cloud architectures with shared responsibility models.

Role Significance

Likely managing a team of 3-8 QA professionals and validation specialists, while collaborating closely with cross-functional teams totaling 20-30 professionals across Product Management, Development, DevOps, and Support functions within the Expressionist Business Unit.
This is a senior management position with significant strategic impact, combining technical QA leadership with business unit responsibility and customer-facing expertise. The role sits at the intersection of technical excellence and business outcomes, requiring both deep subject matter expertise and the ability to influence organizational strategy and customer relationships.

Key Projects

Implementation of comprehensive Quality Management System overhauls that align with evolving regulatory requirements and international standards Leading customer validation projects for large pharmaceutical companies implementing new software systems in regulated environments Developing and executing digital transformation initiatives that modernize QA processes while maintaining strict regulatory compliance

Success Factors

Deep expertise in life sciences regulatory frameworks combined with practical software validation experience that enables effective translation of complex compliance requirements into actionable technical solutions and business processes Strong leadership and influence skills that enable effective collaboration across technical and non-technical stakeholders, from software developers to regulatory affairs professionals to C-level executives at customer organizations Continuous learning mindset and commitment to professional development in a rapidly evolving regulatory landscape where new guidelines, technologies, and industry best practices emerge regularly Customer-centric approach that balances regulatory compliance requirements with practical business needs, ensuring that quality assurance processes enhance rather than impede organizational efficiency and market competitiveness

Market Demand

High demand driven by the critical shortage of professionals who combine deep software QA expertise with life sciences regulatory knowledge, particularly those experienced in CSV and GxP compliance, as organizations increasingly rely on software systems for critical business processes and regulatory submissions.

Important Skills

Critical Skills

GxP and 21 CFR Part 11 compliance expertise represents the foundational requirement for this role, as these regulations govern all software systems used in pharmaceutical research and manufacturing. Without deep understanding of these frameworks, the professional cannot effectively ensure product compliance or support customer validation efforts. Software validation methodology and CSV expertise are essential for delivering customer services and ensuring internal product quality. This specialized knowledge combines technical software understanding with regulatory compliance requirements, creating a unique skill set that is highly valued in the life sciences industry. Cross-functional collaboration and stakeholder management skills are critical for success in this role, as the QA Manager must effectively coordinate with technical development teams, business stakeholders, and external customers to ensure quality objectives are met while supporting business goals.

Beneficial Skills

Project management and change management expertise would enhance the professional's ability to lead complex validation initiatives and QMS improvement projects that span multiple organizational functions and customer relationships Data integrity and cybersecurity knowledge are increasingly important as life sciences organizations face growing regulatory scrutiny around data protection and system security, particularly in cloud-based and hybrid system environments Business development and pre-sales support capabilities would strengthen the professional's contribution to revenue generation and market expansion efforts, particularly given the customer-facing aspects of this role

Unique Aspects

This role uniquely combines hands-on technical QA expertise with customer-facing validation services, creating a hybrid position that requires both deep technical skills and strong business acumen in regulated industries
The position offers direct exposure to cutting-edge life sciences research and pharmaceutical development processes, providing insights into emerging scientific trends and regulatory challenges that shape the industry
The role provides opportunity to influence both internal product development strategy and external customer success outcomes, creating a unique perspective on market needs and competitive positioning in the life sciences software sector

Career Growth

Progression to VP-level positions typically occurs within 3-5 years for high-performing professionals in this specialized field, particularly those who demonstrate success in customer-facing roles and business impact metrics.

Potential Next Roles

VP of Quality Assurance or Chief Quality Officer positions overseeing enterprise-wide quality initiatives across multiple business units and product lines Regulatory Affairs Director or VP positions focusing on broader compliance strategy and regulatory submissions for life sciences organizations General Manager or VP positions for life sciences software business units, leveraging deep technical and regulatory expertise to drive business strategy and market expansion

Company Overview

Genedata

Genedata operates as a specialized provider of software solutions for pharmaceutical research and development, with a focus on data management and analysis platforms that support drug discovery and development processes. The company serves a global customer base of pharmaceutical, biotechnology, and academic research organizations.

Genedata maintains a strong position in the life sciences software niche, particularly in the areas of experimental data management and analysis. The company competes with larger enterprise software providers while maintaining specialized domain expertise that differentiates its offerings in the pharmaceutical research market.
Based in Basel, Switzerland, the company benefits from proximity to a major European pharmaceutical hub, providing access to leading pharmaceutical companies, research institutions, and regulatory expertise that enhances product development and customer relationships.
The organization emphasizes scientific rigor and technical excellence, fostering a culture that values both innovation and regulatory compliance. The work environment likely combines the precision required for regulatory compliance with the collaborative approach necessary for software development and customer success.
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