Senior Lead Computer System Assurance (CSA) Specialist

Job Title: Senior Lead Computer System Assurance (CSA) Specialist
Location: Flexible / Remote Options Available
Role Type: Full-Time Senior Leadership
Position Overview
We are seeking an experienced Lead Computer System Assurance (CSA) Specialist to drive innovative, risk-based compliance strategies across highly regulated life sciences projects. In this high-impact, client-facing role, you will act as a principal technical authority providing end-to-end guidance in quality, validation, commissioning, qualification, and software lifecycle compliance.
You will guide multidisciplinary project teams and clients in modernizing their compliance approaches - transitioning from traditional Computer System Validation (CSV) to efficient, defensible CSA models. This includes evaluating intended use, patient safety, product quality, data integrity (ALCOA+), and process risk across automated manufacturing, laboratory, cloud, and IT/OT environments.
Key Responsibilities
Strategic CSA Leadership: Define, implement, and oversee risk-based CSA strategies for GxP computerized systems, automation platforms, lab equipment, and cloud-based applications.
Technical Oversight & Quality Assurance: Review and optimize key compliance deliverables, including validation/assurance plans, functional requirements, risk assessments, traceability matrices, test protocols, and summary reports.
Optimized Testing Methodologies: Apply streamlined assurance methods, leveraging supplier documentation, vendor assessments, scripted/unscripted testing, automated evidence, and targeted verification.
Lifecycle & Audit Support: Lead compliance efforts for change controls, deviations, CAPAs, investigations, lifecycle assessments, RFQs, and regulatory audit readiness.
Mentorship & Capability Building: Educate and mentor engineers, project leads, and quality specialists in modern CSA principles, Good Documentation Practice (GDP), and SDLC risk frameworks.
Client Engagement: Facilitate CSA workshops and technical discussions with key client stakeholders to promote practical, risk-conscious validation solutions.
Required Qualifications
Education: Bachelor’s degree in Engineering, Computer Science, Life Sciences, Quality Assurance, or a related technical field.
Experience: 10+ years of direct experience in computerized systems validation/assurance, automation, quality engineering, or lifecycle compliance within GxP-regulated industries.
Regulatory Expertise: In-depth knowledge of CSA, CSV, GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+ data integrity, and SDLC methodologies.
Risk Management: Proven track record of applying risk-based testing to eliminate unnecessary documentation burdens while maintaining strong compliance and objective evidence.
Soft Skills: Exceptional collaborative mindset, client-facing communication skills, and leadership ability.
Preferred Qualifications
Practical experience establishing or scaling CSA programs within the pharmaceutical, biotechnology, or medical device sectors.
Familiarity with operational technology (OT) validation, cloud-based GxP platforms, AI-enabled validation tools, or digital quality technologies.
Active involvement in industry associations (e.g., ISPE, GAMP).
Background in business development support, scope drafting, and technical client proposals.

Work arrangement
Yes