Qc Functional Lead

30 minutes ago

Singapore WUXI XDC SINGAPORE PRIVATE LIMITED Full time

**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.

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