Senior Quality Specialist - Legal: Risk & Compliance

Senior Quality Specialist - Legal: Risk & Compliance

Job Description

About Signant Health

At Signant Health, we help bring life-changing treatments to patients faster. We are a global evidence generation company that supports clinical trials with smart technology, scientific expertise, and hands‑on operational support — so better data leads to better decisions in healthcare. We embrace AI and advanced technologies to enhance every aspect of what we do, from data analysis to operational efficiency.

Our teams work at the intersection of science, technology, and patient experience, delivering digital solutions powered by AI innovation that make clinical trials more efficient, more accurate, and more accessible around the world. Trusted by leading pharmaceutical companies and CROs, our platforms and services support studies across more than 90 countries and have contributed to hundreds of new drug approvals.

If you are motivated by meaningful work, global impact, and innovation in clinical research and digital health — including the opportunity to work with cutting‑edge AI technologies — you will find purpose and opportunity at Signant Health.

About the Role ( 6 months fix Term position )

The Senior Quality Specialist leads and manages Quality Events and Corrective and Preventive Actions (CAPAs) end-to-end to ensure systematic investigation and resolution of quality issues across clinical trial operations. The role is accountable for driving issues from initial identification through root cause analysis, CAPA implementation, and effectiveness verification ensuring quality issues are not only resolved but prevented from recurring. In this senior capacity, the role also serves as a key quality resource for cross-functional teams and customer-facing engagements, applying advanced expertise to complex investigations and systemic quality challenges.

Through rigorous investigation practices, cross-functional collaboration, and evidence-based decision making, the Senior Quality Specialist applies risk-based approaches to prioritizing actions and drives continuous improvement. The role monitors quality trends to identify systemic gaps and ensures corrective actions deliver sustained results. Additionally, the Senior Quality Specialist acts as a quality champion, supporting the development of junior team members, contributing to quality strategy, and representing the quality function in customer and audit forums.

KEY ACCOUNTABILITIES

Quality Event Management

• Manages the full Quality Event lifecycle from initiation through closure, ensuring thorough documentation in the Quality Management System (QMS).
• Assesses and assigns criticality classifications based on impact to participant safety, data integrity, and regulatory compliance.
• Develops clear problem statements that define the performance gap and scope of investigation.
• Leads thorough investigations to understand what happened, how it was discovered, contributing factors, and immediate containment actions.
• Coordinates cross-functional input from Subject Matter Experts and stakeholders to ensure comprehensive issue resolution.
• Supports timely customer notification and communication for events impacting clinical studies.

Root Cause Analysis & Trend Management

• Determines root cause using structured methodologies commensurate with event criticality, documenting findings and rationale.
• Evaluates potential impact to other products, projects, or customers and initiates appropriate cross-functional actions.
• Performs trend analysis of historical Quality Events to identify patterns, recurring issues, and systemic gaps.
• Leverages trend insights to inform preventive actions and drive continuous improvement initiatives.

CAPA Management

• Develops and documents corrective and preventive actions that address identified root causes.
• Ensures CAPA descriptions are specific, measurable, and achievable with clear ownership and accountability.
• Tracks CAPAs through implementation to closure, ensuring actions are fully completed with appropriate evidence.
• Manages timeline adherence and escalates risks appropriately when extensions are required.

Effectiveness Verification

• Plans and executes Effectiveness Checks to verify corrective actions addressed the root cause and achieved intended results.
• Evaluates whether issues have recurred and documents findings with supporting evidence.
• Identifies opportunities to strengthen controls when effectiveness checks reveal gaps.

Audit Support & Process Improvement

Additional responsibilities may include:

• Provides audit support during internal and external quality audits and inspections, including preparation of documentation, participation in audit activities, and tracking of audit observations and responses.
• Serves as Subject Matter Expert (SME) for review and approval of process improvement Standard Operating Procedures (SOPs) and Work Instructions (WINs), ensuring alignment with quality standards and regulatory requirements.

Quality Metrics & Performance Reporting

• Develops, owns, and presents quality KPI dashboards and trend reports to internal leadership and customers, translating data into actionable quality intelligence.
• Monitors Quality Event aging, CAPA milestone adherence, and overdue action rates, generating periodic management reports and escalation summaries for senior leadership review.
• Contributes to periodic customer quality review meetings, presenting quality event summaries, CAPA status updates, and trend analyses, serving as a primary quality contact for designated accounts.
• Provides structured mentorship and day‑to‑day guidance to Quality Specialists, supporting development of investigation writing, root cause analysis, and QMS documentation skills.
• Reviews and provides quality oversight on investigations, CAPA plans, and effectiveness checks prepared by junior team members prior to QMS submission, ensuring documentation meets GxP standards.
• Supports onboarding of new Quality team members, contributing to training material development and delivery of quality system training.

DECISION MAKING AND INFLUENCE

• Partners with Quality Management to determine appropriate event classification, ownership, and escalation paths.
• Collaborates with cross-functional teams including Operations, Project Management, Technical Delivery, and Customer Delivery to drive resolution.
• Facilitates lessons learned discussions and supports knowledge sharing across teams and departments.
• Mentors cross-functional team members and provides guidance on investigation best practices.
• Independently represents the Quality function in customer-facing quality reviews, audit interactions, and cross-functional governance forums, exercising senior judgment on escalation and communication strategies.
• Contributes to quality strategy by identifying systemic process gaps and recommending SOP, workflow, or technology improvements to Quality Management.

KNOWLEDGE, SKILLS & ATTRIBUTES

• Bachelor’s degree required; degree in Life Sciences, Pharmacy, Engineering, or a related field preferred.
• Minimum five (5) years of experience in a GxP-regulated environment, with at least two (2) years in a quality specialist or equivalent role.
• Demonstrated experience managing Quality Events and CAPAs in a Quality Management System.
• Proficiency in root cause analysis methodologies (e.g., 5-whys, fishbone diagrams).
• Strong understanding of CAPA lifecycle management and effectiveness verification principles.
• Excellent written and verbal communication skills with ability to articulate complex issues clearly.
• Strong analytical thinking and attention to detail in investigation documentation.
• Ability to manage multiple priorities and meet deadlines in a fast‑paced environment.
• Self‑directed with strong organizational and time management skills.
• Demonstrated ability to mentor, guide, and provide quality oversight to junior team members in a GxP-regulated setting.
• Proven ability to independently manage customer‑facing quality communications, including preparation and delivery of quality event summaries and CAPA status updates for customers.
• Experience developing and presenting quality metrics and trend analyses to management and/or customers, with the ability to translate data into meaningful quality narratives.
• Experience in clinical trial operations or life sciences industry.
• Familiarity with ICH guidelines (E6, Q9, Q10) and risk‑based quality management principles.
• Experience with trend analysis and quality metrics reporting.
• Familiarity with software development lifecycle (SDLC) processes and methodologies.
• Quality certifications (ASQ CQA, CQE, or similar) a plus.
• Experience authoring, reviewing, or owning GxP SOPs and Work Instructions as a Subject Matter Expert.
• Exposure to clinical trial technology platforms (e.g., RTSM, eCOA, EDC) and understanding of how system configurations impact data integrity and regulatory compliance.

Why Signant Health?

At Signant Health, your work has real impact. Everything we build, support, and deliver helps advance clinical research and bring new treatments to patients faster — improving lives around the world. Our teams combine science, technology, and operational expertise to solve complex clinical trial challenges, and every role contributes to that mission.

We offer a collaborative, global environment where you can grow your career while working alongside experts across clinical, technology, data, and operations, with opportunities to learn, take ownership, and drive meaningful innovation — not just maintain the status quo.

If you are looking for purpose-driven work, smart colleagues, and the opportunity to help shape the future of clinical research and digital health, Signant Health is the place to do it.

Unsolicited resumes submitted by agencies or third-party recruiters directly to hiring managers or any Signant Health employee will not be considered and will not obligate Signant Health to any fees or terms associated with the submission.

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. We are proud to be an equal opportunity workplace and an affirmative action employer, 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. Prior to their start date, all candidates are required to be verified through a thorough background check and identity verification to confirm eligibility for employment.