Third Party Management Specialist

Role Summary

As a Third Party Management Specialist, you will ensure the quality and compliance of our pharmaceutical third-party partnerships by evaluating, qualifying, and certifying suppliers based on their quality systems and capabilities. You will develop quality agreements, establish audit programs to assess GMP/GDP compliance, and drive continuous improvement initiatives while identifying and mitigating risks. Your role involves resolving quality issues, managing corrective actions, and maintaining proper documentation of all third-party activities. Success requires experience in pharmaceutical quality management systems, strong analytical and communication skills, audit expertise, and project management capabilities to oversee multiple quality initiatives while ensuring regulatory excellence and patient safety.

Responsibilities

• Evaluating and qualifying new Third Party and when applicable, certifying Third Party based on their quality systems, capabilities, performance history and Quality Control expertise.
• Ensuring that all third-party activities comply with relevant legal and regulatory requirements (e.g., QSMP).
• Ensuring proper documentation and record-keeping of all third-party quality activities and communications.
• Driving continuous improvement initiatives with Third Parties to enhance product quality and process efficiency.
• Developing and maintaining quality agreements and Technical Specifications (PTS, STS) with Third Parties, outlining quality expectations and responsibilities.
• Establishing an annual audit program of third-party facilities to assess compliance with applicable regulatory requirements (GMP / GDP) and internal documents.
• Identifying and mitigating risks associated with Third Parties through risk assessments and implementation of corrective actions.
• Ensuring the resolution of quality issues related to Third Parties, including audit observation, deviations, non-conformances, and Third Party complaints as well as supporting customer complaints.
• Monitoring the progress and timely implementation of any CAPA addressing quality issues or supporting continuous improvement

Qualifications

• Required: 1+ years of experience in third-party quality management systems, QA or related areas in the pharmaceutical industry.
• Required: Experience in quality management systems in the pharmaceutical industry.
• Required: Ability to analyze complex data, identify trends, and make data-driven decisions to improve quality and compliance.
• Required: Strong verbal and written communication skills to effectively interact with third-party suppliers, internal teams, and regulatory bodies.
• Required: Proficiency in conducting thorough and effective audits of third-party suppliers to ensure compliance with quality standards and regulations.
• Required: Excellent problem-solving abilities to address and resolve quality issues, including root cause analysis and implementation of corrective actions.
• Required: Strong project management skills to oversee multiple quality initiatives, manage timelines, and ensure successful completion of projects.
• Required: Fluent in English, both written and spoken.
• Preferred: Bachelor's degree (Life Sciences, Business Administration or related fields).
• Preferred: Experience using Veeva.

Skills

• Quality management systems
• Auditing of third-party suppliers
• Data analysis and trend identification
• Regulatory compliance knowledge
• Supplier relationship management
• Project management
• Documentation and record-keeping

Education

• Bachelor's degree (Life Sciences, Business Administration or related fields) - preferred