Director Digital Quality Transformation

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 Sharps 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 Sharps 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 Sharps 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.

• 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 to ensure ongoing compliance.

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:

Bachelors 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.