Brief Job Description

Responsible for the establishment and maintenance of the Quality Management System (QMS) of ADC products under the Drug Marketing Authorization Holder (MAH) system and supervising the quality management process of ADC products in a comprehensive manner to ensure that the product quality complies with GMP requirements. The quality and compliance of products during the whole process from Contract production to marketing release shall be guaranteed under continuous improvement of QMS.

Typical Accountabilities:

Establishment and maintenance of Quality Management System (A Certificate) of ADC products

Specific Responsibilities/Tasks

• Being responsible for establishing and maintaining the Quality Management System of ADC products that comply with the requirements of the drug regulatory authorities and ensuring regulatory compliance.
• Contract Production Supervision:
  • Regularly evaluate QMS of the entrusted party (CMO) to ensure it continues to meet the standards stipulated in the contract and fulfil the obligations stipulated in the Quality Assurance Agreement (QAA) to ensure effective integration of QMS of both parties.
  • Support GQA regular on-site inspection of the QMS of Contract Manufacturing Enterprise to ensure that it continues to comply with legal requirements.
  • Ensure that personnel meeting the qualification requirements are stationed in the Contract Manufacturing Enterprise during the entrusted manufacturing of drugs and carry out on-site guidance and supervision over the whole process of production management and quality management to ensure that the production processes, quality standards, etc. comply with regulatory requirements.
• Establish a GMP document system covering the product of Contract production and ensure the accessibility of all documents and data directly related to the product.
• Supplier and material management:
  • Support EQ to evaluate and approve material suppliers.
  • Support GQA to conduct on-site inspection of the QMS of major material suppliers.
  • Ensure management of Incoming Quality Control of materials (API, Excipients and Packing materials), and regularly conduct spot check review of Incoming Quality Control results of CMO to ensure that the relevant materials meet pharmaceutical requirements and legal Specifications.
• Product release:
  • As a Delegated of Qualified Person, ensure that all products to be marketed have been strictly reviewed before release, including batch analysis records, batch production records, deviation handling, OOS investigation, etc., to achieve the product quality target and comply with GMP requirements and registered specification.
  • Ensure the quarterly review and analysis of quality management, production management, etc. of entrusted production to ensure the improvement of QMS.
• Ensure the compliance of the quality control laboratory and supervise the whole process of Contract Analysis.
• Quality risk management of co-production line: Ensure the formulation and implementation of cross-contamination control measures for the entrusted product, and to ensure product quality safety.
• Sampling analysis of API, excipients and finished products: the conduct of spot analysis shall be ensured, including regular spot analysis and the spot inspections triggered by significant deviation, major change, major adverse trend.
• Ensure the good implementation of the post-marketing change control system related to ADC products, and effectively evaluation and risk control for the change of the entrusted product.
• Establish the Self-Inspection system for entrusted production, monitor the implementation of relevant quality management system, and form self-inspection records.
• Compliance monitoring and annual quality activities: To ensure that all operations are in compliance with the current laws, regulations and internal policies, to ensure the completion of annual product quality report and annual drug report, and to submit necessary updates to the regulatory authorities.

• Cross-function collaboration: Work closely with other functions to promote product quality improvement plans.

• Establish a communication mechanism with CMO: as a liaison between the MAH quality department and the external CMO, convey the company's quality requirements and expectations in a timely manner; Maintain good communication with CMO to keep abreast of changes in their supply chain in a timely manner; Establish an effective information feedback channel to quickly respond to potential problems.

Education, Qualifications, Experience and Capabilities

Education, Qualifications, Experience

• Master and above of Pharmacy, Chemistry, Biology, Biochemistry or relevant majors
• Over 10 years of practical experience in quality and production management in pharmaceutical industry, with at least 3 years of experience in quality management of Antibody-Drug Conjugate (ADC) or biological products; those with experience in MAH system operation give priority

Capabilities

• Regulatory knowledge: Familiar with GMP regulations such as NMPA and EMA, familiar with ICH guidelines and requirements, familiar with relevant provisions of MAH system, and professional knowledge in the quality and production management of biological products， quality control and product production processes.
• Good inspection management, analysis solving problems abilities
• Up-to-date understanding of industry technologies and regulations