Head of Quality Assurance

Job Title: Head of QA, Director / Senior Director QA Location: Onsite in ChinaFull time, permanent Job Responsibilities:Lead the design, establishment, and continuous improvement of the company’s Quality Management System (QMS) to ensure compliance with applicable regulatory and GMP requirements supporting manufacturing, testing, and distribution activities.Oversee the implementation of key quality system elements, including documentation control, training management, and overall compliance oversight.Allocate resources and supervise operations across Manufacturing, Engineering, IT & Digitalization, Quality Control, and Materials Management to ensure compliance with GMP standards.Review and approve quality management system documents in accordance with established procedures.Review and approve suppliers, including material and service providers, according to qualification and performance evaluation procedures.Review and approve quality events such as deviations, out-of-specification (OOS) results, complaints, returns, recalls, and associated CAPA activities in line with established procedures.Review and approve change controls, qualification, and validation activities in accordance with defined processes.Assign personnel and resources to support Chemistry, Manufacturing and Controls (CMC) project operations, ensuring GMP compliance and adherence to project timelines.Coordinate internal, client, regulatory, and third-party audits by ensuring appropriate resource allocation and readiness.Serve as the responsible person overseeing validation activities of facilities, utilities, systems, and automated production equipment to maintain compliance with current GMP standards.Coordinate qualification and validation of facilities, utilities, systems, and process equipment in collaboration with system owners and project teams to maintain the validated state.Periodically update validation schedules related to facilities, utilities, systems, and process equipment to ensure continued compliance.Implement and maintain quality systems related to qualification and validation lifecycle management, ensuring alignment with corporate standards and regulatory expectations.Prepare and/or approve validation plans and protocols (e.g., DQ, IQ, OQ, PQ) as well as corresponding summary reports.Generate, review, and approve qualification deviations and ensure timely closure according to procedural timelines.Review vendor Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) documentation and coordinate execution of testing with internal teams and suppliers.Present validation and qualification status of facilities, utilities, systems, and processes to clients, auditors, and regulatory inspectors.Maintain approved quality documentation covering the entire validation lifecycle, including VMPs, VPs, URS, FS, OS, protocols, and reports.Identify and define validation requirements for proposed changes, corrective, and preventive actions.Ensure adherence to and continuous improvement of the company’s Quality Management System and compliance programs.Lead recruitment, development, and performance management of the Validation team.Plan and manage validation budgets, including capital equipment and consumables, ensuring cost control and alignment with departmental goals.Promote a culture of safety, compliance, and operational excellence through effective leadership and adherence to approved safety and quality procedures.Ensure compliance with all corporate and site safety standards, targeting zero lost-time injuries.Lead the daily operations of the Quality Assurance department and ensure information security and data integrity compliance across all quality systems.EducationBachelor’s degree or above in a relevant scientific or engineering discipline; an advanced degree is preferred.ExperienceMinimum of 8 years of experience in a quality-regulated industry (pharmaceutical, biotechnology, or medical device). Experience in QA and regulatory submissions in China or international markets is an advantage.Extensive experience in GMP quality systems and validation within licensed pharmaceutical or biologics facilities (NMPA, EMA, or FDA).Proven leadership experience managing QA and validation functions, particularly during new facility start-up or major system upgrades.Knowledge and SkillsIn-depth knowledge of GMP regulations, quality systems, and related international guidelines.Expertise in validation and qualification practices, aseptic processing, and pharmaceutical utility systems.Strong understanding of Good Engineering Practices, system design, factory testing, and commissioning.Proficiency in analyzing complex data sets, performing statistical evaluations, and preparing validation reports.Strong organizational, project management, and problem-solving abilities with excellent attention to detail.Demonstrated leadership in building and managing high-performance teams.Excellent written and verbal communication skills in English, with proficiency in technical documentation.Proficiency in Microsoft Office applications and other common digital tools used in QA and validation environments.Strong budgeting, planning, and financial control experience.