The posting
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.
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 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. Recognized IT auditor, Certified Auditor accreditation or information security qualification (e.g. CISA, QICA, CISSP, CRISC, ISO27001 Lead Auditor, SSCP) preferred.
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-motivation 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. 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. Prolonged use of computer and headphones for conference calls. Communicate effectively via phone, video, and email. Use hands and fingers to operate a computer and other office equipment. Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus.
Travel Requirements: Minimal
