QA Senior Specialist (Quality System)

Job SummaryEstablish an effective quality management system and ensure it runs smoothly.Responsibilities Oversee the establishment and maintenance of an effective quality system, ensuring full compliance with the latest regulatory requirements.Manage the entire documentation lifecycle, ensuring accuracy and control.Be responsible for personnel training initiatives.Oversee change control management, ensuring all changes are thoroughly assessed before implementation.Conduct regular reviews and assessments of quality metrics to ensure continuous improvement.Establish and implement a comprehensive Quality Risk Management Plan, ensuring timely execution and tracking mitigation efforts (if any) to completion.Facilitate regular quality management review meetings in accordance with internal policies.Handle product complaints efficiently.Take charge of regulatory surveillance and compliance, continuously monitoring regulatory changes, including but not limited to FDA, EMEA, PIC/S, cGMP, and other relevant guidelines. Lead gap assessments and ensure timely implementation of necessary updates.Lead internal and external audits.Manage product recalls when necessary.Perform other tasks assigned by leadership.QualificationsBachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.At least 8 years of working experience in production and/or quality management, with a minimum of 5 years in production QA or quality system QA.Familiarity with FDA, EMEA, and PIC/S GMP requirements.Experience in setting up quality systems for new sites is preferred.Experience with biopharma commercial quality systems is preferred.Proficient in English listening, speaking, reading, and writing.Skilled in Microsoft Word, Excel, PowerPoint, etc.Strong learning ability.Effective at cross-functional communication and collaboration.About WuXi XDC WuXi XDC Cayman Inc. (“WuXi XDC” , stock code: 2268.HK) is a leading global CRDMO focused on antibody drug conjugates (ADC) and the broader bioconjugate market. It provides end-to-end contract research, development and manufacturing services for bioconjugates, including ADCs. Its services cover antibody intermediates and other biologics intermediates, chemical payloads and linkers, as well as bioconjugate drug substances and drug products. WuXi XDC has been successful in bringing multiple ADC projects to the Investigational New Drug (IND) filing stage in 15 months or less, nearly cutting in half the traditional development timeline. As of June 2023, 110 on-going integrated projects are under development at WuXi XDC, including 47 post-IND bioconjugate projects, among which 16 projects are in phase II/III. For more information about WuXi XDC, please visit: https://wuxixdc.com