[Remote] Quality Business Partner - Operations & Commercial

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.