Vendor and Third-Party Management Quality and Compliance Manager

This is a fully remote position, open to applicants in Poland.

📋 Description

• Oversee Quality Events, Quality Issues, deviations, and associated investigations in collaboration with relevant stakeholders.

• Serve as the Deviation Owner and assist in the definition, implementation, tracking, effectiveness assessment, and closure of CAPA.

• Aid in internal and external audit processes, ensure audit readiness, and address audit findings effectively.

• Guarantee that quality records, documentation, and evidence are comprehensive, accurate, traceable, and ready for inspection.

• Provide support for third-party governance and oversight from a quality and compliance viewpoint.

• Participate in third-party Quality Risk Assessments related to GMA activities, including NIS, RWE/RWD, Research Collaborations, and partnerships.

• Recognize, evaluate, and escalate risks associated with third-party due diligence, qualification, and oversight.

• Ensure adherence to SOPs, business guidelines, quality standards, and regulatory requirements.

• Assist in Research Collaboration and specific non-vendor third-party due diligence and assessment efforts.

• Collaborate with stakeholders and third parties to gather due diligence information and documentation.

• Maintain and enhance TPM due diligence tools, such as TPIAT.

• Lead or act as a subject matter expert in designing, revising, implementing, and improving GMA V&TPM quality, compliance, and governance processes, standards, procedures, and guidance.

• Offer quality and compliance expertise, guidance, and training to operational teams and stakeholders.

• Work alongside Quality Assurance, Medical QA, Medical Governance & Risk Management, Procurement, Vendor & Partner Governance, and other stakeholders.

⛳️ Requirements

• Bachelor's degree in a life science or healthcare-related field.

• Prior experience in Vendor & Third-Party Management, Quality Assurance, Compliance, or a similar position supporting clinical research or Medical Affairs activities.

• Required clinical trial/Medical Affairs experience within a pharmaceutical company or Contract Research Organization (CRO).

• Experience collaborating with external suppliers, research partners, and cross-functional stakeholders in a pharmaceutical or CRO environment.

• Familiarity with clinical/medical affairs processes and activities, demonstrating excellent study management understanding.

• Solid comprehension of clinical and Medical Affairs processes, study management activities, and related external services.

• Strong knowledge of regulatory requirements in Clinical Research and drug development.

• Comprehensive understanding of the international pharmaceutical product development process.

• Proficient in GxP requirements, quality management systems, risk management, and regulatory standards from major Health Authorities.

• Broad knowledge of FDA and EMA standards, along with ICH regulations and guidelines.

• In-depth understanding of Quality Management Systems, GCP/GVP requirements, audit processes, CAPA management, and risk management principles.

• Familiarity with procurement processes and the clinical external supplier landscape, including CROs, Central Labs, specialty services, eCOA, and new technologies.

• Proven experience and capability to manage/supervise third parties and external suppliers.

• Good understanding of clinical data systems/platforms and the integration of clinical data systems and processes.

• Proficient in written and spoken English.

• Strong problem-solving, negotiation, and conflict resolution skills.

• Detail-oriented, diligent, accurate, accountable, capable of multitasking, service-oriented, and proficient with numbers.

🏝️ Benefits

• Competitive salary.

• Attractive benefits package.

• Comprehensive medical care plan: Health, Dental & Vision.

• Life Assurance coverage.

• Exceptional work environment.

• Culture focused on teamwork and collaboration.

• Access to innovative technology.

• Excellent training opportunities.

• Long-term position with career progression possibilities.