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Allentown, Pennsylvania, United States
Onsite
The Director Digital Quality Transformation is responsible for leading the modernization of Quality systems, processes, and governance frameworks that enable digital innovation, operational excellence, and sustainable business growth across Sharp's U.S. operations.
This role serves as the strategic Quality leader for digital transformation initiatives, ensuring that emerging technologies, integrated enterprise platforms, automation solutions, and artificial intelligence capabilities are implemented in a manner that strengthens product quality, patient safety, data integrity, and regulatory compliance. The position partners closely with Operations, IT, Engineering, Supply Chain, Commercial, and Customer organizations to create connected, data-driven, and scalable quality processes that enhance customer experience, accelerate decision-making, and support value creation.
Reporting to the Vice President, Quality, SPS-US, this role is accountable for establishing and maintaining the Quality governance, validation strategy, and lifecycle management frameworks necessary to support enterprise systems including ERP, LIMS, eQMS, MES/eBR, LMS, environmental monitoring systems, automation platforms, advanced analytics, and AI-enabled technologies. The Director ensures these capabilities are deployed and managed in accordance with global regulatory expectations while advancing Sharp's digital manufacturing and quality vision.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The following is a list of responsibilities related to the Director, Digital Quality Transformation position. Other duties may also be assigned.
Digital Quality Strategy and Governance
· Develop and execute a multi-year Digital Quality roadmap aligned with Sharp's business strategy, customer expectations, operational growth objectives, and quality transformation initiatives.
· Establish Quality governance frameworks that ensure appropriate oversight, ownership, accountability, and lifecycle management of digital quality systems across the enterprise.
· Support the integration of digital platforms and data architectures to enable connected, efficient, and compliant end-to-end business processes.
· Serve as the Quality representative and advisor for enterprise digital transformation initiatives, ensuring quality requirements are incorporated from concept through deployment and ongoing operation.
· Champion the adoption of modern quality practices that leverage 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 in accordance with current regulatory expectations, GAMP 5 principles, and Computer Software Assurance (CSA) methodologies.
· Provide oversight for the 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 associated with GxP technologies and computerized systems.
· Ensure digital systems maintain 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 within 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 where AI and advanced analytics can improve product quality, process performance, compliance monitoring, and operational decision making.
· Ensure appropriate controls are established to support data reliability, model governance, algorithm performance monitoring, and regulatory defensibility.
· Digital Enablement and Business Growth
· Partner with Operations, Supply Chain, Engineering, and Commercial teams to deploy digital capabilities that enhance scalability, improve customer responsiveness, and support business growth.
· Enable the development of 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 to position Sharp as a leader in digital quality and pharmaceutical manufacturing excellence.
Inspection Readiness and Regulatory Support
· Ensure all digital quality systems maintain a state of inspection readiness and support successful 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.
QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
· Lead and influence cross-functional teams across Quality, IT, Engineering, Validation, Data Analytics, Operations, and Supply Chain functions.
· Provide coaching and technical leadership to system owners, business process owners, and quality professionals involved in digital transformation initiatives.
· Foster a culture of innovation, collaboration, continuous improvement, and data-driven decision making.
· Develop organizational capabilities that strengthen digital literacy, quality systems expertise, and technology adoption throughout the organization.
· Effectively manage project portfolios, resources, priorities, risks, and stakeholder communications to ensure successful delivery of strategic initiatives.
SUPERVISORY RESPONSIBILITIES:
This position does not have any direct reports, but will lead cross-functional teams tasked with assessment, sourcing, implementation, qualification and/or life cycle maintenance of electronic software solutions including ERP, LIMS, eQMS, MES, AI tools, etc.
PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:
To be successful in this role, the following education and experience is preferred:
· Bachelor’s degree in Life Sciences, Engineering, Information Technology, Computer Science, or 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.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
The employee is frequently required to sit, occasionally required to stand, walk and reach with arms and hands. The employee may occasionally need to lift and/or move objects up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision and ability to adjust focus.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is required to sit at a desk, periodically walk to the shop floor and occasionally drive to another Sharp location in Pennsylvania. The work environment is clean and not normally subject to hazardous conditions or environment.
DISCLAIMER:
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.