Director Digital Quality Transformation

Sharp Packaging Services•Allentown, PA

About The Position

The Director Digital Quality Transformation leads the modernization of Quality systems, processes, and governance frameworks across Sharp's U.S. operations. The role serves as the strategic Quality leader for digital transformation, ensuring emerging technologies, enterprise platforms, automation, analytics, and artificial intelligence are implemented in ways that strengthen product quality, patient safety, data integrity, and regulatory compliance. It partners with Operations, IT, Engineering, Supply Chain, Commercial, and Customer organizations to develop connected, data-driven, scalable quality processes that improve customer experience, decision-making, and business value. Reporting to the Vice President, Quality, SPS-US, the Director establishes and maintains Quality governance, validation strategy, and lifecycle management frameworks for enterprise systems such as ERP, LIMS, eQMS, MES/eBR, LMS, environmental monitoring systems, automation platforms, advanced analytics, and AI-enabled technologies. The role ensures these capabilities meet global regulatory expectations while advancing Sharp's digital manufacturing and quality vision. The Director develops a multi-year Digital Quality roadmap; provides governance and lifecycle oversight for digital quality systems and GxP computerized systems; leads Quality oversight of AI and emerging technologies; and works with business and technology teams to enable digital capabilities, analytics, customer integration, and business growth. The role also maintains inspection readiness, serves as a subject matter expert for inspections and audits, and leads responses and remediation related to computerized systems, data integrity, or digital processes. It has no direct reports but leads cross-functional teams responsible for electronic software solution assessment, sourcing, implementation, qualification, and lifecycle maintenance.

Requirements

Bachelor’s degree in Life Sciences, Engineering, Information Technology, Computer Science, or a related technical discipline.
At least 10 years of experience in pharmaceutical, biotechnology, or regulated life sciences industries within GMP environments.
At least 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, computerized system validation 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.
Demonstrated leadership experience managing cross-functional initiatives.
Strong analytical, strategic thinking, project management, and communication skills.
Ability to lead and influence teams across Quality, IT, Engineering, Validation, Data Analytics, Operations, and Supply Chain.
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.
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 use of digital technologies, automation, advanced analytics, and artificial intelligence to improve quality performance and operational effectiveness.
Establish and maintain risk-based validation and lifecycle management strategies for GxP computerized systems, consistent with regulatory expectations, GAMP 5, and Computer Software Assurance methodologies.
Oversee implementation, qualification, maintenance, periodic review, and retirement of regulated computerized systems.
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 and signatures, and system access management.
Lead Quality governance and oversight for AI, machine learning, predictive analytics, and emerging technologies used in regulated quality and manufacturing processes.
Establish AI frameworks for qualification, validation, monitoring, transparency, traceability, human oversight, and risk management.
Partner with business and technology leaders to identify uses of AI and advanced analytics to improve product quality, process performance, compliance monitoring, and operational decision-making.
Establish controls for 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.
Support customer digital integration initiatives that improve transparency, collaboration, data exchange, and operational efficiency.
Drive adoption of technologies that improve speed, accuracy, compliance, and productivity while reducing complexity and manual activities.
Evaluate emerging technologies and industry trends related to digital quality and pharmaceutical manufacturing.
Maintain inspection readiness for digital quality systems and support regulatory inspections and customer audits.
Serve as the Quality subject matter expert during regulatory inspections, customer audits, and due diligence assessments involving 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.
Coach and provide technical leadership to system owners, business process owners, and quality professionals involved in digital transformation.
Foster innovation, collaboration, continuous improvement, and data-driven decision-making.
Develop organizational capabilities in digital literacy, quality systems, and technology adoption.
Manage project portfolios, resources, priorities, risks, and stakeholder communications to deliver strategic initiatives.
Lead cross-functional teams assessing, sourcing, implementing, qualifying, and maintaining electronic software solutions, including ERP, LIMS, eQMS, MES, and AI tools.