Quality Assurance Validation & IT, Director in United States at Jobgether
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Job Description
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Quality Assurance Validation & IT, Director in the United States.
This leadership role sits at the core of IT quality, validation, and compliance within a highly regulated clinical research environment. You will oversee QA teams responsible for IT audits, computerized systems validation, and GxP compliance across internal operations and external vendors. The role combines strategic oversight with hands-on quality leadership, ensuring that systems, processes, and infrastructure meet stringent regulatory expectations. You will act as a key partner to IT, vendor management, and business stakeholders to maintain inspection readiness and strengthen quality frameworks. With a strong focus on data integrity, risk management, and continuous improvement, you will shape how computerized systems are validated and maintained across their lifecycle. This is a high-impact role where your expertise directly supports regulatory compliance and the development of life-changing therapies. You will also contribute to building a strong quality culture through training, mentoring, and cross-functional collaboration.
- Lead and manage QA teams responsible for IT audits, validation activities, and quality oversight of computerized systems.
- Oversee IT and vendor audits (internal, external, and for-cause) to ensure compliance with GxP, regulatory, and internal standards.
- Drive Computer System Life Cycle (CSLC) quality oversight, including validation, change control, maintenance, periodic review, and decommissioning.
- Review and approve audit plans, reports, validation documentation, deviations, investigations, CAPAs, and effectiveness checks.
- Ensure robust data integrity and compliance with Electronic Records and Electronic Signatures (ERES) requirements.
- Partner with IT, vendor management, and business teams to ensure alignment on quality and compliance expectations.
- Support regulatory inspections and sponsor audits, ensuring inspection readiness across systems and processes.
- Monitor SaaS and IT vendors using risk-based approaches and performance indicators.
- Contribute to quality risk management activities by identifying audit trends and mitigation strategies.
- Lead continuous improvement initiatives to enhance IT quality systems, SOPs, and compliance frameworks.
- Support training programs and mentor QA staff to strengthen organizational expertise in validation and IT quality.
- Bachelor’s degree or equivalent combination of education and professional experience.
- 10+ years of experience in CRO, pharmaceutical, clinical research, or related regulated industries.
- At least 5 years of experience in SDLC, software testing, validation, and IT auditing (internal and vendor).
- Strong knowledge of GxP regulations, computerized systems validation, and quality assurance frameworks.
- Experience working with SaaS environments, IT systems, and regulated digital infrastructure.
- Proven ability to lead QA teams and manage complex, cross-functional quality operations.
- Strong expertise in audits, inspections, deviations, RCA, and CAPA management.
- Excellent communication skills with the ability to collaborate across IT, business, and compliance teams.
- Strong analytical thinking, risk assessment, and problem-solving abilities.
- Fluent English required, with strong documentation and regulatory writing skills.
- Competitive compensation aligned with experience and industry standards.
- Comprehensive health, dental, vision, and wellness benefits.
- Paid parental leave and generous vacation policies supporting work-life balance.
- Remote and hybrid work flexibility depending on role requirements.
- Career development opportunities through mentoring programs, leadership training, and tuition reimbursement.
- Exposure to global clinical research initiatives impacting patient care and therapeutic development.
- Strong organizational culture focused on quality, collaboration, and continuous learning.