When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
TECHNOLOGY QUALITY OVERSIGHT SPECIALIST
About the Role
Join Parexel's Technology Quality team to support quality oversight across our technology solution lifecycle. You'll provide validation expertise, risk assessment support, compliance monitoring, and inspection readiness for GxP and business-critical systems.
Partner with business stakeholders, Solution Validation Services, Digital and Technology, and Corporate Quality to ensure technology solutions remain compliant, fit for intended use, and inspection-ready throughout their lifecycle.
Key Responsibilities
- Provide quality oversight for technology solution development, validation, implementation, and maintenance.
- Independently review validation packages, including requirements, risk assessments, testing evidence, traceability, and validation reports to ensure compliance and inspection readiness.
- Monitor compliance with regulatory requirements, industry standards, and established procedures.
- Serve as a Quality Representative for technology quality issues, audit findings, CAPAs, and compliance initiatives, partnering with stakeholders to drive timely and effective resolution.
- Facilitate root cause analysis activities, remediation planning, and CAPA development to address technology-related compliance and validation issues.
- Assess AI-enabled solutions and emerging technologies for quality and compliance.
- Support customer audits, regulatory inspections, and internal audits by serving as a technology quality subject matter expert and facilitating responses to validation and compliance inquiries.
- Assist with supplier and vendor quality assessments.
- Maintain inspection-ready documentation and support audit readiness.
What We're Looking For
Required Experience
• 3–5 years in computerized system validation, technology quality, clinical research, pharmaceutical quality, or GxP-regulated environments
• Experience supporting technology projects and validation activities
• Knowledge of SDLC, validation lifecycle, change control, CAPA, and risk management
Key Skills
• Working knowledge of computerized system validation principles
• Understanding of GxP regulations (GCP, electronic records/signatures)
• Knowledge of risk management and quality systems
• Strong analytical, problem-solving, and communication skills
• Excellent stakeholder management abilities
• Ability to prioritize multiple activities in a fast-paced global environment
Preferred Qualifications • Experience with Veeva, ServiceNow, Power BI, or AI-enabled systems • Audit or inspection support experience • Knowledge of GAMP 5, Computer Software Assurance, or AI governance principles
Education
Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Pharmacy, Quality Management, or related discipline; or equivalent combination of education and relevant experience.
Why Join Parexel?
Be part of a global Clinical Research Organization committed to quality and compliance. Support cutting-edge technology solutions while building expertise in GxP validation and emerging technologies like AI.
Skills Required
- 3-5 years in computerized system validation, technology quality, clinical research, pharmaceutical quality, or GxP-regulated environments
- Experience supporting technology projects and validation activities
- Knowledge of SDLC, validation lifecycle, change control, CAPA, and risk management
- Working knowledge of computerized system validation principles
- Understanding of GxP regulations (GCP, electronic records/signatures)
- Knowledge of risk management and quality systems
- Strong analytical, problem-solving, and communication skills
- Excellent stakeholder management abilities
- Ability to prioritize multiple activities in a fast-paced global environment
- Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Pharmacy, Quality Management, or related discipline; or equivalent experience
- Experience with Veeva, ServiceNow, Power BI, or AI-enabled systems
- Audit or inspection support experience
- Knowledge of GAMP 5, Computer Software Assurance, or AI governance principles
Parexel Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.
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Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
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Retirement Support — Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
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Leave & Time Off Breadth — Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.
Parexel Insights
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
