供应商及第三方管理质量与合规经理 - FSP

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