QC Director/Senior Director

Key Responsibilities 1. QC Laboratory Management • Develop and implement quality control strategies to ensure QC laboratory operations comply with international regulatory requirements, including FDA, EMA, NMPA, PMDA, and other applicable regulations. • Lead and organize QC laboratories in preparation for and participation in regulatory inspections, such as PAI inspections, GMP inspections, unannounced inspections, and customer audits. • Ensure QC laboratory compliance in analytical method transfer, method verification, method validation, and routine testing operations. • Lead and coordinate QC laboratories to establish unified quality standards and analytical methods for commercial products. • Manage product quality-related quality events, including change controls, deviations, and OOS investigations. • Collaborate with supply chain planning to support release testing for commercial and clinical products. • Develop and oversee QC laboratory budgets, optimize resource allocation, and improve operational efficiency. • Ensure robust operation of the QC laboratory system and drive continuous improvement. • Ensure safe operation of QC laboratories, with no critical incidents or personal injuries. • Lead continuous improvement initiatives across QC laboratories and promote the sharing and implementation of best practices. • Represent the company in communications with industry associations and regulatory authorities to stay current with regulatory updates and industry trends. • Collaborate with cross-functional teams to support company projects. • Complete other tasks assigned by supervisors. 2. Performance Management and People Development • Set QC laboratory objectives and ensure company strategies and goals are clearly understood, effectively executed, and successfully achieved. • Lead problem-solving initiatives and establish standardized workflows to improve performance management. • Set clear goals for QC team members, guide them in achieving objectives, and support and motivate their career development. • Ensure the efficient and effective operation of the QC team. Job Requirements • Bachelor’s degree or above in Pharmacy or a related field. • At least 15 years of practical experience in quality management within the pharmaceutical industry, including hands-on experience in quality control. • Strong ability to make sound judgments and effectively address issues arising in quality management. • In-depth understanding of pharmaceutical regulations in major global markets, especially QC-related regulatory requirements, such as FDA, EMA, ICH, NMPA, and others. • Extensive experience in global QC compliance audits, including direct experience with regulatory inspections. • Strong knowledge of QC laboratory compliance requirements, including method validation, data integrity, and laboratory controls. • Excellent risk assessment and risk management capabilities, with the ability to identify potential compliance risks and develop effective mitigation strategies. • Outstanding communication and interpersonal skills, with the ability to work effectively with internal and external stakeholders at all levels. • Strong analytical thinking and problem-solving skills, capable of managing complex compliance issues. • Proven ability to collaborate effectively across departments and functions. • Proficiency in both English and Chinese. • Proficient in Microsoft Office applications, including Windows, Word, and Excel.