QC Functional Lead

WuXi XDC; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A leading biotechnology firm in Singapore is seeking a QC Functional Lead to oversee QC project activities and ensure compliance with regulatory standards. The ideal candidate will have at least 2 years in the biotech industry, strong project management skills, and excellent communication abilities. Key responsibilities include client communication, internal collaboration, and documentation management. A bachelor's degree in a relevant discipline is required.

Qualifications

• Minimum 2 years of experience in the biotech or biopharmaceutical industry.
• Knowledge of project management, stability management, and method validation.
• Familiarity with regulations from FDA, EMA, NMPA, and ICH.

Responsibilities

• Lead QC project planning and execution to meet project scope.
• Serve as the primary client contact for QC-related matters.
• Prepare and manage QC activity schedules for timely completion.

Skills

Project management

cGMP principles

Analytical skills

Communication skills

Problem-solving skills

Education

Bachelor’s degree in Pharmacy, Chemistry, Biochemistry, Analytical Chemistry

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.