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.
Job Overview
The Third Party Quality Lead (TPQL) reports to the Head of Third Party Quality. The TPQL works with stakeholders and relevant oversight teams for third party quality risk management, issues management and general Good Clinical Practice guidance. The TPQL maintains Quality-to-Quality contacts with major vendors and site entities partnering with Clinical Development & Operations (CD&O). The TPQL is responsible for assessing and ensuring that clinical trial third party partners have the appropriate quality systems infrastructure, including a culture of quality and compliance to adhere to sponsor's policies and procedures with all applicable external regulatory requirements relating to GCP including those related to patient safety, data integrity, and protocol adherence as set out in the Master Services Agreement. The TPQL the vendor engagement framework, including processes, tools, roles and sourcing strategy.
Job Responsibilities:
Third Party Quality & Risk Management
Identify, evaluate and respond to GCP quality risks related to vendor and site engagement
Lead quality discussions with key vendors and sites and present quality point of view at relevant oversight meetings
Provide quality oversight reports to appropriate sponsor's management / functions
Communicate key quality information (e.g., inspection / audit learnings) across vendors and site entities and serve as quality expert for third parties
Validate, monitor and close out GCP-quality-related action plans
Evaluates quality performance at an enterprise level to inform continuous improvement of quality risk management
Informs site organization relationship owner of quality improvement considerations
Support QMS09 BPO in the development and implementation of process updates
Support Vendor Leads / Business Owners to ensure compliance with functional level vendor oversight requirements
Qualifications:
• BS--7+ years or equivalent
• MS/MBA – 6+ years or equivalent
Previous Experience:
• Minimum of 5 years of pharmaceutical experience with solid
experience in clinical trial development.
• Robust knowledge in quality areas (i.e. audit, inspection,
compliance, and inspection readiness fields)
• Quality related experience including working knowledge in:
o Quality and compliance management, QC
o Root Cause Analysis
o Risk identification, controls, mitigations, and actions
o Metrics development and utilization
o Audit and Inspection conduct and CAPA response process
• Ability to develop strategies using coordinated and transparent
metrics to track and manage compliance
• Ability to participate in cross-line global initiatives or root cause
analysis for quality related process improvement
Skills Required
- BS with 7+ years or equivalent
- MS/MBA with 6+ years or equivalent
- Minimum of 5 years in pharmaceutical clinical trial development
- Robust knowledge in quality areas: audit, inspection, compliance
- Quality-related experience in quality and compliance management
- Ability to develop strategies for compliance tracking
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.
