Senior Director – Quality Engineering, Distributed Controls & CSIA Assurance (Pharma & Biotech)

Job Title: Senior Director, Quality Engineering, Distributed Controls & CSIA Assurance (Pharma & Biotech)
Location: Flexible / Remote Options Available
Role Type: Executive Leadership
Position Overview
We are seeking a high-impact Senior Director of Quality Engineering, Distributed Controls & CSIA Assurance to shape the future of digital quality, smart manufacturing compliance, and enterprise testing strategies across commercial pharmaceutical, biotechnology, and advanced therapy (CGT) platforms. In this executive-level role, you will act as the principal strategic authority, aligning industrial operational technology (OT), Distributed Control Systems (DCS), Programmable Logic Controllers (PLC), and system integration lifecycle workflows with the CSIA (Control System Integrators Association) Best Practices & Benchmarks Framework to build scalable, high-performance, and audit-ready digital quality engines.
You will lead multidisciplinary global engineering teams and advise executive life sciences stakeholders on transforming legacy computer validation into a modernized, risk-based Computer System Assurance (CSA) model, championing automated evidence generation, AI-enabled testing, and continuous quality architectures across complex distributed automation topologies while maintaining unyielding compliance with GxP, patient safety, data integrity (ALCOA+), and FDA/EMA regulatory mandates.
Key ResponsibilitiesVision, Controls Governance & Pharma Modernization
Distributed Controls & CSIA Governance: Establish, standardize, and govern the QMS and SDLC architectures for automated drug manufacturing and laboratory operations, ensuring strict alignment between CSIA Best Practices, GAMP 5 (Second Edition), and FDA CSA guidelines across distributed architectures.
Strategic QE & Control Systems Leadership: Define and execute the global Quality Engineering (QE) and automation strategy across complex control layers, including DCS (e.g., DeltaV, PCS 7), PLCs, SCADA, MES, laboratory information management systems (LIMS), cloud platforms, and enterprise IT/OT environments.
AI & Frontier Tech Integration: Pioneer the deployment of Generative AI, machine learning-driven defect analytics, self-healing automated test suites, and AI-assisted validation protocol execution to radically accelerate release cycles and lower operational validation overhead.
Legacy CSV to CSA Transformation: Lead the enterprise shift from traditional, document-heavy CSV methodologies to streamlined, risk-conscious CSA paradigms, embedding continuous testing into GxP CI/CD pipelines and industrial control software releases.
Control System Testing & Enterprise Quality Execution
Distributed System Test Automation: Architect enterprise test automation frameworks leveraging hardware-in-the-loop (HIL) simulation, software-in-the-loop (SIL) testing, synthetic batch data generation, and zero-touch regression suites for distributed control architectures and batch processing platforms (ISA-88/ISA-95).
Data Integrity & Regulatory Compliance: Enforce enterprise standards for industrial data integrity (ALCOA+), 21 CFR Part 11, EU Annex 11, and CSIA project management and delivery standards across all digital assets, field networks, and historian infrastructures.
Audit Defense & Risk Management: Lead complex GxP change controls, deviation investigations, CAPAs, and serve as the primary executive technical authority during regulatory inspections (FDA, EMA, MHRA) and customer quality audits.
Talent, Operations & Commercial Strategy
Team Leadership & Capability Building: Build, scale, and mentor global teams of Quality Engineers, Automation Architects, Control System Engineers, and CSIA Systems Assurance Specialists, fostering a culture of technical rigor, agile execution, and regulatory excellence.
Executive Client & Business Engagement: Serve as the executive technical sponsor for strategic life sciences client partnerships, RFQs, and industry workshops, demonstrating how CSIA-aligned validation frameworks reduce time-to-market and total cost of compliance.
Required Qualifications
Education: Master’s or Bachelor’s degree in Electrical Engineering, Automation/Control Systems Engineering, Bioengineering, Computer Science, or a related technical discipline.
Experience: 15+ years of progressive executive leadership in Quality Engineering, Industrial Control Systems (ICS), System Integration, CSV/CSA, and Software Assurance within regulated Pharmaceutical, Biotech, or Life Sciences Consulting environments.
Distributed Controls & OT Expertise: Deep domain expertise in industrial control architectures, Distributed Control Systems (DCS), PLC/SCADA integration, batch control (ISA-88/ISA-95), industrial communication protocols, and OT network security.
CSIA & GxP Standards Expertise: Extensive experience applying CSIA Best Practices & Benchmarks across automation integration, SDLC, project execution, and quality management in GxP environments.
Regulatory Mastery: In-depth technical mastery of FDA CSA guidelines, GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+, and ICH Q9 Risk Management principles.
Enterprise Automation: Proven track record of scaling automated testing frameworks across both enterprise life sciences IT systems and manufacturing OT/DCS control layers.
Preferred Qualifications
Active involvement or leadership roles within CSIA, ISPE, GAMP, IEEE, or ISA working groups.
Direct experience implementing AI-enabled validation tools (e.g., automated protocol generation, AI-driven test maintenance, or predictive control loop defect modeling).
Technical depth in Cloud Native GxP architectures (AWS/Azure/GCP), Smart Factory / Industry 4.0 initiatives, Edge Computing, and automated continuous manufacturing platforms.
Proven success driving business development, drafting commercial proposals, and delivering C-suite client presentations for multi-million-dollar pharmaceutical digital transformation and control system integration programs.

Work arrangement
Yes