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