Note: The job is a remote job and is open to candidates in USA. Signant Health is a global leader in digital solutions for clinical research, committed to bringing life-changing clinical trials to patients. They are seeking a Quality Business Partner to provide strategic quality guidance to Commercial and Operations, ensuring compliance with regulatory standards and integrating quality into business processes.

Responsibilities

Partner with business leaders to understand objectives and create quality requirements
Provide quality guidance during planning and process development
Define and implement Quality Programs tailored to each business unit's regulatory and contractual requirements within the broader Quality framework
Assess quality risks and develop mitigation strategies
Serve as quality expert for assigned business teams
Provide guidance to software development teams during development process
Integrate quality systems into business workflows
Lead improvement initiatives to enhance quality and efficiency
Establish quality metrics and performance indicators
Identify 'Quality Waste' in inefficient or duplicate processes, procedures and documentation.
Support business unit develop, review, and modify standard operating procedures (SOPs) and work instructions for business processes whilst balancing efficiency and risk
Create, maintain, and manage quality risk registers and risk plans with business units Support business unit to ensure compliance with quality standards and regulations by designing and executing internal audit procedures to assess compliance with policies and procedures
Assess training needs and develop quality programs
Guide, coach and mentor business teams on quality best practices, audit readiness and regulatory compliance
Create and/or support quality dashboards and reports for leadership
Monitor performance trends and provide insights
Lead and develop the Product Oversight team to ensure quality excellence
Define team priorities, objectives, and performance metrics
Coordinate Product Oversight activities across business units
Ensure consistent application of quality standards and regulatory requirements
Build team capabilities through coaching, mentoring, and professional development

Skills

Bachelor's degree in Engineering, Business, or Quality Management
5+ years quality management or process improvement experience
Business partner or consulting experience preferred
Knowledge of quality systems (ISO 9001, GAMP 5, ISO 27001 etc.)
Knowledge in GxP regulations with proven experience implementing compliant processes and ensuring inspection readiness
Proficiency in quality tools (Six Sigma, Lean, SPC)
Strong communication and analytical skills
Project management abilities
Quality certifications (ASQ CQE, CQM, Black Belt)
Multi-functional experience (operations, R&D, IT, product)
Digital Quality tools knowledge

Company Overview

Signant Health focuses on software solutions for remote and site-based eCOA, eConsent, IRT, supply chain management, and data analytics. It is a sub-organization of Genstar Capital. It was founded in 2018, and is headquartered in Blue Bell, Pennsylvania, USA, with a workforce of 1001-5000 employees. Its website is https://www.signanthealth.com/.

Company H1B Sponsorship

Signant Health has a track record of offering H1B sponsorships, with 5 in 2022, 9 in 2021, 5 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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[Remote] Quality Business Partner - Operations & Commercial