Senior Quality Assurance Specialist – Computer Systems and Data Integrity - Quality & Regulatory Systems

Overview

LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.

We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.


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Job Summary

The Senior Quality Assurance Specialist is responsible for ensuring that computerized systems used in GxP-regulated environments are validated and maintained in compliance with applicable regulations. This role also ensures that data integrity principles are upheld throughout the system lifecycle, supporting quality assurance and regulatory compliance.

The ideal candidate will stay current with evolving systems, data privacy regulations, security strategies, and CSV compliance procedures in a dynamic and growing organization. Success in this role depends on the ability to navigate a complex regulatory landscape, client expectations while ensuring internal alignment and accountability.
This position is ideally suited for candidates within commuting distance to Johnson City, TN or in the Eastern US time zone.

Essential Duties and Responsibilities

◦ Oversee all aspects of Computer System Validation activities for both newly implemented and modified systems through the entire software life cycle, ensuring compliance with regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11) and internal quality standards. Collaborate cross-functionally with IT, and system owners to align on validation strategies, oversee documentation, and ensure timely execution of validation deliverables throughout the system lifecycle.

◦ Plan and perform audits of IT and technology vendors, Review audit findings and validation reports to assess compliance gaps and system risks. Actively participate in root cause analysis (RCA) sessions and collaborate with cross-functional SMEs to agree/approve robust and effective Corrective and Preventive Actions (CAPAs)

◦ Assist with risk assessments of new and proposed technologies including contributions to Artificial Intelligent (AI) advisory team

◦ Create, Approve and ensure internal LC SOPs and processes are designed for regulatory compliance as applicable to computerized systems and data integrity, data privacy (e,g GxP, FDA 21 CFR Part 11, and EU Annex 11)

◦ Ensure proper documentation for CSV and Data Integrity projects, including risk control metrices, compliance assessments, process narratives, testing, issue evaluation, and reporting.

◦ Manage and execute day-to-day compliance operational tasks, including client and vendor IT questionnaires, compliance metrics reporting, audit finding responses, internal audits, and document reviews.

◦ Conduct comprehensive IT supplier qualification reviews to assess the compliance, reliability, and data integrity practices of third-party vendors.

◦ Ensure life cycle management of GxP Computerized systems through QMS policies, documentation and change control.

◦ Prepare KPIs in support of quality reporting to management. Assist in other QA tasks as assigned, including Veeva Vault workflows, reporting and configurations.
◦ Identify opportunities for continuous quality improvement by analyzing validation processes, audit findings, and system performance metrics. Develop and implement actionable plans to enhance compliance, efficiency, and data integrity across computerized systems. Keep abreast of regulatory and IT compliance developments and evolving best practices in compliance control and data integrity.
Education and Experience


◦ Bachelor’s degree in information technology or related field; and 6 years of relevant experience 4+ years of experience working in at least one of the following regulatory settings: FDA 21 CFR 11, Annex 11, ISO 27001, SOX, HIPAA, HITECH, CLIA, CAP, GCP.
◦ Experience in clinical trials and clinical laboratory, biotech or Pharma industry with focus on computerized systems, IT processes and regulatory compliance.


◦ Specific QA roles overseeing computerized systems life cycle and DI policies and procedures.
◦ Experience with core IT applications used in a regulated environment, including Veeva, LIMS etc.


Skills and Ability

◦ Ability to take the initiative, dependable, and work with little supervision while being resilient to change
◦ Ability to work within a fast-paced, cross-cultural, and cross-functional team environment
◦ Ability to adhere to established timelines, processes and procedures
◦ Excellent attention to detail.
◦ Strong planning and problem-solving skills.
◦ Self-motivating and ability to work well independently as well as using a collaborative team approach.
◦ Ability to adapt to changing environments and requirements.
◦ Excellent organization and time management skills, communication, multitasking, interpersonal and listening skills.
◦ Ability to adhere to quality and regulatory requirements while still meeting business needs.
◦ Public speaking skills
◦ Business acumen.
◦ Proficient in Microsoft Office Suite.


Certificates and Licenses

◦ Recognized IT auditor, Certified Auditor accreditation or information security qualification (e.g. CISA, QICA, CISSP, CRISC, ISO27001 Lead Auditor, SSCP) preferred.


Language Ability

◦ Ability to read, analyze, and comprehend technical client correspondence, meeting agendas and meeting notes. This position requires the incumbent be able to communicate with peers at pharmaceutical and biotechnology firms in a professional manager that reflects well upon LabConnect LLC.


Math Ability

◦ Ability to apply simple mathematical skills and abstract thinking in a logical and organized manner.


Reasoning Ability

◦ Ability to solve practical problems, investigate issues, draw correct and logical conclusions; the ability to understand a verity of technical instructions, mathematical and diagrammatic representations of data in both an abstract and concrete manner.


Computer Skills

◦ To perform this job successfully, an individual must have working knowledge of Microsoft Office applications including word processing software, spreadsheet software, PowerPoint, and MS Project and database software.


Supervisory Responsibilities: None
Physical Demands:

While performing the duties of this job, the occupant is regularly required to:

◦ Prolonged periods of sitting at a desk and working on a computer 95% of the time
◦ Prolonged use of computer and headphones for conference calls 95% of the time
◦ Communicate effectively via phone, video, and email
◦ Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus


One Global Team

At LabConnect, we are proud to be one global team: united by our shared mission to advance clinical trials through innovation, agility, and collaboration. We believe that our people are our greatest asset, and we are committed to fostering a workplace that reflects our core values: People First, Quality Focused, Customer Centered, Technology Driven, and Accountability Always.

LabConnect is an Equal Opportunity Employer. We celebrate diversity and are dedicated to creating an inclusive environment for all employees. We do not discriminate based on race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), creed, national origin, age, disability, genetic information, veteran status, or any other legally protected status. We are committed to cultivating a workplace that is safe, equitable, and respectful for all.Together, as one global team, we strive to ensure that every individual has the opportunity to thrive and contribute to our shared success.

This job description should not be construed to imply that these requirements are the exclusive standards of the position. Incumbents will follow any other instructions and perform other related duties as may be required by their supervisor. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of the job.


Read more below and get ready for your next great employment adventure!


Some of the Perks our LabConnectors Love:

• Financial Security (base pay, 401k match and possible annual bonus eligibility)
• Health Benefits beginning on date of hire
• PTO plan plus 11 Paid Company Holidays and 1 day to Volunteer in your community
• Short and Long-Term Disability, Life and AD&D
• We celebrate our differences, which enrich our Culture

We are a growing and global team which Values People First, Quality Focused, Customer Centered, Technology Driven and Accountability Always. In addition to great perks and challenging work assignments, we invest in our people with enriching career growth opportunities.


We believe in a friendly and collaborative environment with open lines of communication. Join our team and discover how your work can impact the lives of people all over the world.


It is the policy of LabConnect to provide equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information, or any other protected characteristic under applicable law.


Equal Employment Opportunity Posters:

https://www.dol.gov/agencies/ofccp/posters


If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please email talent@labconnect.com or call +1(423)722-3155.


For more information, visit www.labconnect.com