Leader, Technology Quality & Compliance

Leader, Technology Quality & Compliance

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Rollenberichte an:

Senior Director Technology Quality

Ort:

North America, United States, New Jersey, Summit

Arbeitsort:

Hybrid

Was Sie tun werden

Technology Quality and Compliance (TQ&C) manages the Quality and Compliance strategy for Technology systems including applications, infrastructure and digital health solutions. TQ&C is the Subject Matter Expert (SME) for validation/qualification of both applications and infrastructure in accordance with the company’s Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the enterprise with applicable global regulations, advising on quality matters, and assisting with addressing compliance gaps related to audits and inspections.

The Leader TQ&C Americas is responsible for building and execution of quality into enterprise-wide systems, tools, services and infrastructure through the end-to- end lifecycle (design, develop, implement, maintain, retire)

• This position engages project /product teams ensuring early involvement of TQ&C in the design and development of applications and infrastructure, building quality into the work product and controls within the application/solution, leveraging automation whenever feasible

• The individual ensures company quality standards and regulatory requirements are met for the project/product teams under scope of responsibility

• The role is responsible for planning, executing, coordinating and maintaining the validation activities for GxP projects/technology product teams within their scope including approval of SDLC validation documentation, release system implementation and/or changes for production use, providing TQ&C compliance guidance and support to project team members

• The individual reviews and approves SOP, WIs and policies related to regional processes and systems within their scope and supports the incident management/CAPA and NC processes for the region supported

• This position will support internal audits, Health Authority regulatory inspections and system periodic reviews ensuring a high level of inspection readiness for projects/technology products/systems under their responsibility

• Responsible for the management of consultants and outside service providers assigned to execution activities and provides risk-evaluation guidance to TQ&C Leads and consultants to carry out validation of computerized systems and infrastructure.

• Serves as the TQ&C SME for regional CSV requirements, engages with Regulatory Compliance to support regulatory standards and trends monitoring evaluation activities and analyzes impact of guidance documents applicable to the region.

What we are looking for

Required Qualifications

• A minimum of a Bacherlor’s  degree or equivalent advanced education in a relevant technical, scientific, or related field.

• 8 to 10 years of progressive experience in technology quality management, validation, quality assurance, or related fields within regulated industries.

• Proven expertise in designing and managing validation programs aligned with current regulatory requirements and industry best practices.

• Strong knowledge of Quality Management Systems and applicable regulations.

• Project Management certification or formal training with demonstrated experience managing complex projects and cross-functional teams.

• Excellent communication and leadership skills.

Desired Qualifications

• Exceptional ability to leverage data-driven insights and emerging technologies to transform quality processes and outcomes.

• Strong leadership acumen with experience managing diverse and globally dispersed teams and influencing cross-functional stakeholders at senior leadership levels.

• Preferred training or certification in Computer Systems Validation (CSV) and familiarity with software development lifecycle (SDLC) methodologies such as Agile.

• Advanced skills in financial planning, budget management, and resource allocation within a technical department.

• Demonstrated ability to apply Six Sigma, Lean, or other process excellence methodologies to drive quality and operational improvements.

• Strong technical literacy including familiarity with automation, machine learning applications, and quality compliance monitoring tools.

• Proven aptitude for strategic thinking, problem-solving, and driving organizational change to elevate quality standards and customer satisfaction.

• Ability to foster innovation, continuous learning, and knowledge sharing through benchmarking, training, and performance monitoring.

#LI-SR1

Was haben Sie davon

$124,100.00 - $175,200.00

Dies berücksichtigt eine Reihe von Faktoren, darunter den Arbeitsort, die Fähigkeiten des Kandidaten, die Erfahrung, das Bildungsniveau und die andere berufsbezogene Faktoren.

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