[Skip to main content](#main-content) [OpenNash Jobs](https://jobs.opennash.com/) [Hiring report](/reports/hiring/) · [All Roche Holding jobs](https://jobs.opennash.com/companies/roche-holding/) · [Search jobs](/search/) Roche Holding · Shanghai # Associate Manager, QA Biologics 生物制药QA副经理 Shanghai Full-time Manager or lead Research & Science Listed on Roche Holding’s official careers site. Posted September 30, 2026. Check that it is still open and apply there. [Apply on Roche Holding’s careers site →](https://roche.wd3.myworkdayjobs.com/roche-ext/job/Shanghai/Associate-Manager--QA-Biologics_202602-105031) [OpenNash Jobs](https://jobs.opennash.com/) / [Roche Holding](https://jobs.opennash.com/companies/roche-holding/) / Associate Manager, QA Biologics 生物制药QA副经理 ## Job description At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Principle Roles & Responsibilities / Accountabilities主要职责/责任 Quality and Technical Guidance Play the role of quality oversight, provide immediate support and guidance during the project phase and RCPT routine GMP operation, including but not limited imported DS material release, master manufacturing record establishment, aseptic filling & package operation oversight, quality evaluation on any issues or queries that may arise during product handling. Develop, review and maintain comprehensive quality documentation (manuals, SOPs), ensuring they comply with GMP/GDP/Roche requirements, are up-to-date, and accessible. Evaluate new suppliers and service providers based on quality criteria and regulatory requirements, and collaborate during external/internal audits and health authority inspections. Perform thorough risk assessments to identify potential quality risks, develop and implement risk mitigation strategies Responsible for ensuring that product quality issues are correctly investigated, and that appropriate corrective and preventative actions are implemented. Review deviation/exception/ investigation reports, Assure the efficient, timely, batch record review and CGMP compliant materials and products release. Support and represent QA during audits and inspections; may directly interact with regulatory agencies during on-site inspections. Maintain project timelines associated with initiatives to support the evolving business. Participate in tech transfer, collaboration with other functions to ensure the success of new product manufacturing. Support the compliance, regulatory and training activities as required, Support the continuous improvement and oversight of QA Compliance programs and identifies and implements new technologies to improve the compliance and efficiency of QA operations. Other related duties as assigned. Qualification and Experience 能力与经验 Education/Qualifications The candidate should have at least a Degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, or a related discipline. Certification and trainings such as auditor training will be advantageous. Leadership Competencies Models Integrity Focus on value and customer Align for success Deliver results Learn for the future ### Job Required Competencies A minimum experience of 7 years in pharmaceutical or biotechnology in quality assurance, GMP compliance, operations or validation, ideally in a multinational company. Aseptic Filling experience is required and experience in the new DP facility project is expected. FDA/EU cGMP know-how and a thorough understanding of ICH guidelines, together with exposure to the international regulatory network. Able to logically solve problems in order to find timely solutions. An ability to interact and communicate with all types of personalities in an effective and diplomatic manner Good decision-making capability Experienced in new facility startup readiness and operation ramp up Fluent communications skills in English and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer. ## At a glance - Posted by the employer: Sep 30, 2026 - First seen by OpenNash: Jul 16, 2026 - Last checked: Oct 18, 2026 - Listed for: 94 days - Location: Shanghai - Employment type: Full-time[Apply on Roche Holding’s careers site →](https://roche.wd3.myworkdayjobs.com/roche-ext/job/Shanghai/Associate-Manager--QA-Biologics_202602-105031) ## More jobs at Roche Holding ### [(Senior) Analyst, Microbiology and EM Lab, Biologics 微生物与环境监测实验室（高级）分析员](https://jobs.opennash.com/companies/roche-holding/jobs/0e4da14d1235ec47f408/) Shanghai ### [(Senior) Scientist, Protein Engineering](https://jobs.opennash.com/companies/roche-holding/jobs/096f4c8b49bd2a7d50b0/) Shanghai ### [(Sr.) Specialist, LS & ASAT, Biologics 生物制剂QC实验室支持与分析科学技术（高级）专员](https://jobs.opennash.com/companies/roche-holding/jobs/36e8d14452d6255cc421/) Shanghai ### [AM, Lab Support & ASAT, Biologics 生物制剂QC实验室支持与分析科学技术副经理](https://jobs.opennash.com/companies/roche-holding/jobs/18d9de5b513da8802700/) Shanghai ### [Associate Manager - P/C Analytical Laboratory](https://jobs.opennash.com/companies/roche-holding/jobs/795f3485982581a66fb5/) Shanghai ## Similar jobs at other companies ### [Principal Research Scientist I Ii Biologics Quality Control In Biologics Analytical R And D All Gend In Ludwigshafen Rp Jid 32265](https://jobs.opennash.com/companies/abbvie/jobs/2eefea6545cb504c37e7/) AbbVie ### [Global Process Engineer Biologics In Worcester Ma Jid 27537](https://jobs.opennash.com/companies/abbvie/jobs/58bc17fc7841fab6f627/) AbbVie ### [Scientist– Biologics Analytical Sciences](https://jobs.opennash.com/companies/zoetis/jobs/17b31601263480444d14/) Zoetis ### [Associate Director, Regulatory Affairs, CMC- Biologics](https://jobs.opennash.com/companies/alnylam-pharmaceuticals/jobs/eedf15801e22c49f813b/) Alnylam Pharmaceuticals · Cambridge ### [Senior Patent Agent- Biologics](https://jobs.opennash.com/companies/neurocrine-bioscience/jobs/0a7ea0d27f332b778fff/) Neurocrine Biosciences · US CA San Diego OpenNash lists jobs from employers’ own careers sites and does not handle applications. Dates come from the employer where stated; “first seen” and “last checked” are our own observations. OpenNash Jobs · Official listings with dates and links to the employer. [Weekly hiring report](/reports/hiring/) · [Methodology](/methodology/)