Quality Director Jobs

About The Position

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Information Technology, Computer Science, or a related technical discipline.
• Minimum 10 years of experience in pharmaceutical, biotechnology, or regulated life sciences industries within GMP environments.
• Minimum 5 years of experience implementing, managing, or supporting enterprise digital quality systems or digital transformation initiatives.
• Strong knowledge of GxP, eQMS, change management, deviation management, CSV qualification, and regulatory compliance requirements.
• Experience with computerized system validation (CSV) and GAMP 5 lifecycle management.
• Experience supporting compliance with 21 CFR Part 11 and EU Annex 11 requirements.
• Demonstrated leadership experience managing cross-functional initiatives.
• Strong analytical, strategic thinking, project management, and communication skills.
• Ability to lead and influence cross-functional teams and provide coaching and technical leadership.
• Ability to manage project portfolios, resources, priorities, risks, and stakeholder communications.

Responsibilities

• Develop and execute a multi-year Digital Quality roadmap aligned with business strategy, customer expectations, operational growth objectives, and quality transformation initiatives.
• Establish Quality governance frameworks for oversight, ownership, accountability, and lifecycle management of digital quality systems across the enterprise.
• Support integration of digital platforms and data architectures for connected, efficient, compliant end-to-end business processes.
• Represent and advise Quality in enterprise digital transformation initiatives, incorporating quality requirements from concept through deployment and ongoing operation.
• Promote modern quality practices using digital technologies, automation, advanced analytics, and artificial intelligence.
• Establish and maintain risk-based validation and lifecycle management strategies for GxP computerized systems in accordance with regulatory expectations, GAMP 5 principles, and Computer Software Assurance methodologies.
• Oversee implementation, qualification, maintenance, periodic review, and retirement of regulated computerized systems.
• Ensure compliance with applicable global regulations and guidance, including FDA, EU GMP, PIC/S, ICH, MHRA, data integrity requirements, 21 CFR Part 11, and EU Annex 11.
• Review and approve validation strategies, risk assessments, system classifications, and qualification approaches for GxP technologies and computerized systems.
• Ensure digital systems have appropriate controls for data integrity, cybersecurity, auditability, electronic records, electronic signatures, and system access management.
• Lead Quality governance and oversight for AI, machine learning, predictive analytics, and emerging digital technologies used in regulated quality and manufacturing processes.
• Establish frameworks for AI qualification, validation, monitoring, transparency, traceability, human oversight, and risk management consistent with evolving regulatory expectations.
• Partner with business and technology leaders to identify opportunities for AI and advanced analytics to improve product quality, process performance, compliance monitoring, and operational decision-making.
• Establish controls supporting data reliability, model governance, algorithm performance monitoring, and regulatory defensibility.
• Partner with Operations, Supply Chain, Engineering, and Commercial teams to deploy digital capabilities that enhance scalability, customer responsiveness, and business growth.
• Enable integrated dashboards, key performance indicators, and advanced analytics that provide actionable insights and strengthen management review processes.
• Support customer digital integration initiatives that improve transparency, collaboration, data exchange, and operational efficiency.
• Drive adoption of technologies that enhance speed, accuracy, compliance, and productivity while reducing process complexity and manual activities.
• Evaluate emerging technologies and industry trends related to digital quality and pharmaceutical manufacturing.
• Ensure digital quality systems remain inspection-ready and support regulatory inspections and customer audits.
• Serve as the Quality subject matter expert during regulatory inspections, customer audits, and due diligence assessments for digital and computerized systems.
• Lead responses, remediation strategies, and continuous improvement actions related to inspection observations involving computerized systems, data integrity, or digital processes.
• Monitor regulatory trends and evolving expectations related to digital systems, AI, data governance, and computerized system validation.
• Lead and influence cross-functional teams across Quality, IT, Engineering, Validation, Data Analytics, Operations, and Supply Chain.
• Provide coaching and technical leadership to system owners, business process owners, and quality professionals involved in digital transformation initiatives.
• Foster innovation, collaboration, continuous improvement, and data-driven decision-making.
• Develop organizational capabilities in digital literacy, quality systems expertise, and technology adoption.
• Manage project portfolios, resources, priorities, risks, and stakeholder communications to deliver strategic initiatives.