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.