岗位职责:
Job Purpose:
The purpose of the quality role at affiliates is to ensure that quality systems are established, adequately managed, implemented and maintained in this organization and integrated into the Bracco corporate Quality Management System (QMS).

Job Description: Quality management and oversight processes in commercial affiliates in China & Hongkong under his/her responsibility will include but are not limited to:

61 Design and implement a comprehensive Quality Management System across commercial affiliates and supply chains to ensure pharmaceutical product quality, efficacy, and safety compliance.

61 Develop and execute quality monitoring plans for distributors, CROs and partners, conducting risk-based audits to ensure compliance with GCP/GDP regulations, company SOPs and standards.

61 Oversee vendor partnerships, evaluate quality systems, maintain Quality and Technical Agreements, and resolve compliance issues to align project timelines with quality goals.

61 Provide quality oversight for key processes including complaint handling, deviations, change control, CAPA implementation, and product recalls.

61 Liaise with internal departments (TechOps, Supply Chain, Regulatory Affairs) and health authorities to ensure effective implementation of global processes, successful project launches, and timely fulfillment of regulatory commitments.
任职要求:
61 Bachelor’s degree or above in Medicine, Pharmacy, Life Sciences, Chemistry or related fields.
61 Minimum 5 years of Quality Assurance experience in pharmaceutical industry or clinical trials; broad understanding of GCP, GDP, ICH guideline.
61 Proven track record in managing commercial affiliate, sites and supporting successful NMPA/FDA inspections.
61 Knowledge and experience of audit, validation, risk assessment, data analysis is highly preferred.
61 Strong communication, analytical & problem solving skill, strategic thinking.
61 Experience of working cross-functionally and in global teams preferred.
61 Proficiency in English in reading and writing, good speaking preferred.
61 Willingness to travel frequently (30% of working time).