Quality Business Partner

At Signant Health, we help bring life-changing clinical trials to patients around the world. As a global leader in digital solutions for clinical research, we partner with top pharmaceutical companies, biotechs, and CROs to simplify trial execution, improve data quality, and accelerate the development of new therapies. Our people are at the heart of our mission — we foster innovation, collaboration, and growth in everything we do.
We are looking for Quality Business Partner to join our team
Position Overview
Strategic quality advisor to Commercial and Operations, providing guidance on what needs to be compliant and why. This role connects the Quality department with business units to build quality into their processes and decision-making while ensuring adherence to regulatory and compliance standards.
Key Responsibilities
Partnership & Consultation
- 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

Quality Integration & Improvement
- 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

Training & Monitoring
- 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

Product Oversight Team Management
- 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
- Build team capabilities through coaching, mentoring, and professional development

**Qualifications**:
**Required**:

- 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

**Preferred**:

- Quality certifications (ASQ CQE, CQM, Black Belt)
- Multi-functional experience (operations, R&D, IT, product)
- Digital Quality tools knowledge

Success Metrics
- Quality performance improvement in business units
- Business unit satisfaction with quality support
- Compliance results and cost reduction

At Signant Health, accepting difference isn’t enough—we celebrate it, we support it, and we nurture it for the benefit of our team members, our clients and our community. Signant Health is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status.