Senior Specialist, Quality System, QA

Major responsibilities

• Change Management Governance: Serve as champaign of site change management process. Maintain the site change management process, ensure compliance with current GMP requirements. Participate in EQV integration and implement global change control system at site as stakeholder per project timeline. Support Global change control process within the site/ function.
• Change Control: Review site-initiated change controls to confirm risks are thoroughly and scientifically assessed, mitigation plans are properly defined. Ensure change controls are appropriately addressed, approved and closed in accordance with QCM.
• Change Review Board: Organize and chair site level change control review meeting with experts (if appropriated) and stakeholders at frequency to ensure comprehensive discussion and alignment on change impact assessment and implementation plan.
• Regional Process: Participate in regional process network, provide feedback improvements/ concerns into regional change process champion.
• Global Change control: Laise with regional process champaign to facilitate sited initiated global change and local change approval, go live and closure.
• Performance: Actively monitor and review Key Performance Indicators at site/ function and escalate trends and signals to line manager, take immediate actions if needed.
• Coach all users at site/ function as local change control process champaign.
• Implement the business continuity plan (BCP) at site/ function as directed by the IT system owner.
• Hands-on support for change related regulatory submission across China/US/EU and timeline planning with RA.
• Participate in Quality Management Review, product review and corresponding quality review as change control champaign.
• 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: Bachelor’s degree in pharmacy, Life Sciences, Biotechnology or related field; Graduates from 985/211 universities or reputable overseas institutions 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 in biologicals, Cell Therapy/ATMP is preferred, MNC background is a plus.
• Technical Knowledge: Strong change control expertise as the process champaign: end-to-end lifecycle (initiation, impact assessment, approval, implementation, effectiveness check, closure), clear stage gates, and KPI management. Proficiency in quality risk management and linking risk outcomes to validation/qualification, data integrity, and regulatory impacts.
• Regulations & Standards: Deep knowledge for China GMP, US FDA 21 CFR, EU GMP, PIC/S, ICH Q9/Q10, ATMP 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 and regional team, and author high quality English documentation.
• Behavioral Attributes: Demonstrates strong ownership, self-motivation and execution. Excels at cross-functional collaboration and prioritization, drives continuous improvement.

Preferred/Optional

• Experience with QMS systems such as Veeva.
• ASQ quality certifications.

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.