QA总监

该职位来源于猎聘 职位描述Job Summary： The Director of Quality Assurance will lead the Quality Assurance (QA) department and ensure compliance with applicable regulatory standards, including FDA, NMPA, EMA, and ICH guidelines. He/she will oversee all aspects of quality systems, ensuring product quality and safety, driving continuous improvement, and fostering a culture of quality excellence throughout the organization. 工作职责Responsibilities： Leadership and Strategy: Develop and implement the QA strategy aligned with the company's business goals. Provide leadership and guidance to the QA team, fostering professional growth and development. Regulatory Compliance: Ensure compliance with cGMP, FDA, EMA, and other international regulatory requirements. Prepare for and lead regulatory inspections and audits, addressing any findings effectively. Quality Systems Management: Oversee the implementation, maintenance, and improvement of quality systems, including CAPA, deviation management, change control, document control, and training programs. Ensure timely review and approval of quality-related documents, including batch records, validation protocols, and SOPs. Product Quality Oversight: Provide oversight for product release, ensuring quality specifications are met. Collaborate with manufacturing, PD, and QC to address quality-related issues and optimize processes. Risk Management: Identify and mitigate quality risks across the product lifecycle. Implement robust quality metrics to monitor and report on quality performance. Continuous Improvement: Drive initiatives to enhance quality systems and processes, ensuring alignment with industry best practices. Stay updated on regulatory changes and industry trends to proactively adapt QA strategies. Stakeholder Collaboration: Act as the primary point of contact for quality matters with regulatory authorities, clients, and partners. Support cross-functional teams in product development, technology transfer, and commercialization activities. 任职资格Qualifications： Education:

Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Biology, or a related field. Experience:

Minimum of 10-15 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry, with at least 5 years in a leadership role. Working experience in MNC or US /EU biopharmaceutical companies is a plus. Knowledge: In-depth knowledge of cGMP, FDA, NMPA, EMA, and ICH guidelines. Very knowledgeable with pharmaceutical manufacturing processes and quality control systems. Skills: Strong leadership, decision-making, and interpersonal skills. Excellent problem-solving and analytical abilities. Effective communication skills, both written and verbal. Fluent in English. Key Competencies Strategic thinking and the ability to align quality objectives with business goals. Strong organizational skills and attention to detail. Adaptability to a dynamic, fast-paced environment. Commitment to fostering a culture of quality and compliance.