Senior Specialist, Quality System, QA

Major responsibilities

• Global Alignment & Harmonization: Map site procedures to corporate/global SOPs harmonize terminology and process flows and drive adoption of global standards templates and metrics. Lead gap assessments and remediation to ensure full integration and consistency.
• Implement ECMS at Suzhou site: Work with global project team to promptly execute global ECMS implementation and project timeline at Suzhou site as local representative.
• Clinical Lifecycle Readiness: Ensure controls support tech transfer from development to GMP clinical supply scaleout/scaleup protocol amendments and eventual commercial transition.
• Document Control: Establish controlled lifecycle management for SOPs policies work instructions forms and templates; ensure controlled issuance versioning approval periodic review and archival in the electronic system.
• Data Integrity: Implement ALCOA/ALCOA principles for paper and electronic procedures and records; perform data integrity risk assessments audits and remediation; collaborate with IT/CSQ to ensure system controls access management and audit trails.
• Training: Maintain rolebased GMP training matrices and curricula; manage onboarding and periodic refreshers; integrate with global training management system.
• Archival: Maintain archives per local procedures and GRAD schedule including site archives and oversight external outsourcing archival.
• Quality Performance: Actively monitor and review Key Performance Indicators related at site/ function and escalate trends and signals to line manager provide routine reports to site leadership and global quality. take immediate actions if needed.
• Implement the business continuity plan (BCP) at site/ function as directed by the IT system owner.
• Leads and influences other quality professionals across the organization to ensure consistent application and execution of key quality systems
• Participate in project teams created towards problem solving or specific issues to ensure GMP and regulatory compliance
• Participate in internal self-inspection or external audit activities.
• Address observations issues or potential risks related to change control process define and implement corrective and preventive actions.
• Proactively participates in company initiatives toward continuous improvement (New Products Introduction GMP Improvement Programs etc.) while providing guidance in the area of knowledge and deliver timely results while contributing to quality system improvement.

Education Qualifications Skills and Experience

• Education: Bachelors degree in pharmacy Life Sciences Biotechnology or related field; Graduates from 985/211 universities or advanced degree are preferred.
• Experience: 5 years of experience within a robust GMP quality system in pharmaceutical with at least 2 years focused on Quality system. Experience within biologicals MNC background is a plus.
• Technical Knowledge: Demonstrated QMS implementation/integration experience organized and detailoriented. Proficiency in quality risk management and linking risk outcomes to validation/qualification data integrity and QMS impacts.
• Regulations & Standards: Deep knowledge for China GMPUS FDA 21 CFR EU GMP PIC/SICH Q9/Q10ATMP and data integrity related guidance. Ability to translate requirements into practical SOPs workflows and training.
• Skills: Excellent communication and presentation skills strong cross-function coordination capabilities rigorous logical thinking strong documentation aligned with ALCOA.
• Language: Excellent English (spoken and written) able to communicate with global quality system team and author high quality English documentation.
• Behavioral Attributes: Demonstrated strong ownership self-motivation and execution. Excels at cross-functional collaboration and prioritization drives continuous improvement.
• Experience with QMS systems such as Veeva Enterprises Quality System.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.