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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.
Major Accountabilities:
Quality Events, CAPAs and Audit Readiness
Manage Quality Events (QEs), Quality Issues (QIs), deviations, and related investigations in collaboration with relevant stakeholders.
Act as Deviation Owner, as appropriate, and support CAPA definition, implementation, tracking, effectiveness assessment, and closure.
Support internal and external audits, audit readiness activities, and the remediation of audit findings.
Ensure quality records, supporting documentation, and evidence are complete, accurate, traceable, and inspection ready.
V&TPM Quality Risk Management and Compliance
Support third-party governance and oversight activities from a quality and compliance perspective.
Support and contribute to third-party Quality Risk Assessments (QRAs) and ensure assessments are completed, documented, and maintained for relevant GMA activities, including non-interventional studies (NIS), real-world evidence and real-world data (RWE/RWD) activities, Research Collaborations (RCs), and partnerships. Follow up on identified risks and associated mitigation actions, as appropriate.
Identify, assess, and escalate potential risks arising from third-party due diligence, qualification, and oversight activities.
Ensure compliance with applicable SOPs, business guidance documents, quality standards, and regulatory requirements.
Research Collaboration/non-vendor Due Diligence and Assessment
Support Research Collaboration (RC) and other selected third-party (non-vendor) due diligence and assessment activities, as required.
Ensure the quality, accuracy, and completeness of due diligence and assessment documentation in TPM systems and tools.
Coordinate with internal stakeholders and third parties to obtain information and documentation required for due diligence and assessment activities.
Support the maintenance and continuous improvement of TPM due diligence tools, including TPIAT (Third-Party Impact & Assessment Tool).
Process Improvement, Training and Stakeholder Collaboration
Lead and/or contribute as a subject matter expert to the design, revision, implementation, and continuous improvement of GMA V&TPM quality, compliance, governance processes, standards, procedures, and guidance documents.
Support the development, revision, and implementation of relevant procedures, standards, and guidance documents.
Provide V&TPM quality and compliance expertise, guidance, and training to operational teams and stakeholders.
Collaborate with ESP Quality Assurance, Medical QA, GMA Medical Governance & Risk Management, Procurement, Vendor & Partner Governance (VPG), and other relevant stakeholders to ensure effective oversight of third-party activities.
Requirements:
Degree in a life science or healthcare-related discipline Previous experience in Vendor & Third-Party Management, Quality Assurance, Compliance, or a similar role supporting clinical research or Medical Affairs activities.
Clinical Trial/Medical Affairs experience in a pharmaceutical company or a Contract Research Organization (CRO) is required.
Experience working with external suppliers, research partners, and cross-functional stakeholders within a pharmaceutical company or CRO environment. Emphasis on business, experience with clinical/medical affairs processes and activities and associated external services, with excellent understanding of study management.
Strong understanding of clinical and Medical Affairs processes, study management activities, and associated external services.
Good knowledge of the regulatory requirements in Clinical Research and drug development:
In-depth knowledge of the international pharmaceutical product development process Experience with GxP requirements, quality management system including risk management and regulatory requirements from main Health Authorities.
A broad understanding of main Health Authorities standards, including FDA and EMA requirements, as well as ICH regulations and guidelines.
Strong understanding of Quality Management Systems, GCP/GVP requirements, audit processes, CAPA management, and risk management principles.
Understanding of procurement processes and Knowledge of clinical external suppliers landscape (CROs, Central Labs, specialty services, eCOA and new technologies…) Experience and ability to manage/supervise third parties and external suppliers.
Good understanding of clinical data systems/platforms and overall integration of clinical data system and processes Language proficiency: fluent written and spoken English knowledge Strong problem-solving, negotiation and conflict resolution skills.
Diligent, detail-oriented, accurate, accountable, multi-tasking, service-oriented, good with numbers Originally posted on Himalayas
