Quality Assurance Validation & IT, Director
New
USFull-TimeDirector
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- 10+ years of experience in CRO, pharmaceutical, clinical research, or related regulated industries.
- Required Skills
- Quality AssuranceSaaS
Requirements
- 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.
Responsibilities
- 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.
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