This role is within a global team responsible for managing material certifications. The position sits within the Global Operations Quality organization of AstraZeneca, and is one of two such positions located in China.

Responsibilities:

This includes, but is not limited to, the Quality System oversight and/or performance of the following activities:

• Author/ Review Certification reports (ECMS)
• Supplier Quality verification as it pertains to material chain of custody (SCA)
• Deviation investigations, quality issue management and escalation (EQV, IMT)
• Maintain schedule adherence (Demand and Capacity) for all certification subprocesses
• Compendial requirements verification
• Change Control Management (EQV)
• SOP management
• LEAN initiatives to simplify and standardize processes (Lean Capability – Individual Contributor)
• Quality Risk Assessment (QRA)

Key Accountabilities

• Collaborates with AZ Sites to achieve schedule adherence
• Facilitates process and system improvements via voice of customer
• Archiving certification documentation as required
• Set up of automated reporting of results process (through GQCLIMS/power Bi)
• Site Liaison contact for QC, PT&D, EQ, etc.
• Initiative and projects supporting certification program and interdependent global processes
• Regulatory Audit support

Supports Quality Management Systems

• Supplier Quality Management support
• Quality Control support
• Manages internal deviations in deviation system
• Manages global change controls
• Manages Risk assessments
• Manages Document Reviews and approvals

In addition to the above Key Accountabilities a Quality Manager is expected to include in their remit the following:

• LEAN strategies
• Demonstrated experience working cross-functionally and managing significant improvement initiatives (e.g., project management skills)
• Strong problem-solving skills
• Strong negotiating/influencing skills

Education, Qualifications, Skills and Experience

Essential

• Bachelor’s degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering
• Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment.
• Strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.
• Excellent oral and written communication skills [English and Mandarin]
• Ability to work independently under his/her own initiative.

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.