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QC Functional Lead

QC Functional Lead

WUXI XDC SINGAPORE PRIVATE LIMITEDSingapore, Singapore, Singapore
8 days ago
Job description

QC Functional Lead

We’re seeking a QC Functional Lead with a strong background in biotechnology or biopharma to join our team. This role offers an exciting opportunity to lead QC project activities, manage client communication, and collaborate cross-functionally to ensure quality, compliance, and project success.

Key Responsibilities

Project Leadership & Management

  • Lead QC project planning and execution, ensuring all team members clearly understand the project scope and deliverables.
  • Monitor QC delivery metrics and KPIs to evaluate process effectiveness and identify areas for improvement.
  • Proactively develop innovative solutions to project challenges and ensure timely delivery of results.
  • Escalate critical issues to senior management when necessary.

Client Communication

  • Serve as the primary contact for clients on QC-related matters, maintaining transparent and professional communication.
  • Understand and address client needs to ensure QC deliverables meet or exceed expectations.
  • Present QC findings, reports, and recommendations clearly and confidently to support client decision-making.
  • Build and sustain strong client relationships as a trusted advisor.
  • Internal Collaboration

  • Work closely with the CMC team to understand project scope and QC requirements.
  • Partner with cross-functional teams to facilitate seamless project execution through development and commercial stages.
  • Documentation & Reporting

  • Prepare and manage QC activity schedules to ensure timely completion.
  • Draft and review GMP documents, including release and stability protocols, testing procedures, and study reports in compliance with regulatory standards.
  • Additional Support

  • Perform other QC-related tasks and projects as assigned by leadership.
  • Qualifications

    Education

  • Bachelor’s degree or above in Pharmacy, Chemistry, Biochemistry, Analytical Chemistry , or a related discipline.
  • Experience

  • Minimum 2 years of experience in the biotech or biopharmaceutical industry .
  • Special Knowledge

  • Knowledge in areas such as project management, specification establishment, stability management, comparability studies, method transfer and validation , and business process optimization .
  • Familiarity with domestic and international regulations (FDA, EMA, NMPA, ICH).
  • Skills & Competencies

  • Solid understanding of drug development, manufacturing, and filing processes (experience with ADC and protein therapeutics preferred).
  • Strong grasp of cGMP principles and quality management.
  • Comprehensive knowledge of QC responsibilities in clinical and commercial filings (IND, BLA, etc.).
  • Excellent communication skills , both written and verbal, with the ability to engage effectively with clients and cross-functional stakeholders.
  • Strong analytical and problem-solving skills , with the ability to identify root causes and drive effective solutions.
  • #J-18808-Ljbffr

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    Qc Functional Lead • Singapore, Singapore, Singapore

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