QA Head(J11577)

职位描述

1、Responsible for establishing and maintaining a high-standard quality assurance procedure in accordance with current China, EU and US GMP regulations, and ensuring consistent compliance of GMP regulations throughout clinical trials, commercial manufacturing and post-marketing quality management.

2、Responsible for QA team management and training to support efficient daily operations of the QA Department. Establish and maintain effective collaboration with all GMP-related functional departments to ensure full implementation of quality policies and procedures across the entire lifecycle of product development, clinical trials and commercial production.

3、Responsible for the control and oversight of overall QA activities including but not limited to review and/or approval of QC testing records, raw material release, supplier qualification, equipment qualifications, process validations, product manufacturing and batch release, GMP environment control, stability study, analytical methods and quality specifications, calibrations, customer complaints, deviation handling, CAPAs, change control management, documentation control, training, risk management, and internal audits.

4、Responsible for maintaining and continuously monitoring the overall quality compliance status for all GMP activities to ensure adherence to the company’s quality policies and applicable regulatory requirements.

5、Responsible for preparing for and leading all regulatory audits and inspections; answering quality-related questions, developing corrective actions and continuous improvement program, and. drafting written responses to inspection findings issued by the regulatory authorities.

6、Responsible for setting up and maintaining communication channels with corporate quality management team (MAH), as well as overseas partners and MAHs per global product registration projects. Collaborate with EU QPs and quality teams from global partners to ensure smooth execution of batch record review and batch release, as well as other relevant quality activities.

7、Responsible for reviewing and approving company’s GMP-related standard operating procedures (SOPs), records, working instructions, qualification/study protocols, and reports.

8、Participating in the audit and assessments of the sub-contract manufacturing sites, third party testing laboratories and other critical GMP service providers.

9、As a key member of company Quality Review Board (QRB), attend all QRB meetings and provide professional advice on behalf of QA Department.

任职要求

1、Master’s degree (or above) in pharmaceutical-related disciplines, including pharmaceutical engineering, biochemistry, medicinal chemistry, pharmaceutics, etc. Graduates from China’s 211/985 universities with overseas study and/or work experience are preferred.

2、Minimum 15 years of working experience in the pharmaceutical industry, including a minimum 10 years of experience working in QA department at sites operating under stringent GMP compliance standards and quality culture (e.g., multinational corporations, and commercially focused leading biotech companies).

3、Hands-on experience in quality management for manufacturing of sterile products is mandatory. Prior QA experiences in commercial-stage biopharmaceutical products (vaccine, antibody, ADC, etc.) is required; experience covering biologics manufacturing processes and quality control is preferred.

4、Fluent in both spoken Chinese and English, with proficiency to use English as a working language.

5、Well-versed in quality regulations and QA procedures governed by Chinese, EU/US GMPs, PIC/s, ChP, EP and USP, and other applicable international guidelines such as ISPE, PDA, ICH, etc.

6、Proven experience in leading/supporting in Chinese regulatory inspections for commercial products is mandatory; experience with pre-approval inspections and/or GMP surveillance inspections by FDA, EMA and competent authorities is a plus.

7、Minimum 5 years of QA team leader experience equipped with solid team management capabilities.

8、Strong coordination and teamwork aptitude, alongside excellent communication skills for liaising with internal staff, external clients and cross-functional departments.

9、Proficient in Microsoft Office, Excel and PowerPoint.