Sr Specialist, Compliance QA

Senior Specialist, QA （Compliance）

Location: Qingdao

Key Responsibilities

• Ensure the effective implementation, maintenance, and continuous improvement of site Quality Systems in compliance with applicable GMP requirements, company quality standards, and procedures.
• Manage and support key Compliance QA processes, including Document Management, Training Management, Change Control, Quality Risk Management, Supplier Quality Management, Deviation Management, and other quality system activities as assigned.
• Provide quality oversight and subject matter expertise to ensure assigned quality processes are effectively executed and maintained in a compliant and timely manner.
• Partner with Manufacturing, QC, Engineering, Supply Chain, and other cross-functional teams to address quality and compliance matters and ensure appropriate follow-up actions are implemented.
• Identify and drive continuous improvement opportunities to enhance the effectiveness and compliance of site Quality Systems.
• Support internal and external audits, regulatory inspections, and other site compliance activities as required.
• Collaborate with Global and Regional Quality teams on quality system and compliance-related activities and initiatives.

Qualifications

• Bachelor’s degree or above in a pharmaceutical-related discipline, such as Pharmacy, Pharmaceutical Sciences, Pharmaceutical Engineering, Medicinal Chemistry, Biotechnology, or a closely related field.
• Minimum 5 years of relevant QA, Compliance, or Quality Systems experience within a pharmaceutical manufacturing environment.
• Strong knowledge of GMP requirements and pharmaceutical Quality Management Systems, with solid hands-on experience in quality system and compliance activities.
• Strong analytical and problem-solving skills, with the ability to work effectively across functions and drive quality-related activities.
• Excellent communication, stakeholder management, and cross-functional collaboration skills.
• Fluent spoken English, with the ability to communicate effectively in meetings and collaborate with global stakeholders.
• Experience working in a multinational pharmaceutical organization or an international quality environment is preferred

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 authorisation and employment eligibility verification requirements.