AstraZenecaPQS Associate Director
AstraZeneca is hiring a PQS Associate Director. Level rates it ; you can apply on AstraZeneca.
Level's read on this job
- Level rates this role Little AI โโโโ: aI is not part of the work.
- The posting mentions Lean, quality management and gmp among its tools and skills.
- Level classes it as a senior role.
- AstraZeneca has 1,300+ other open roles on Level.
AI in this role
Drive regulatory compliance and quality management systems for supply operations as an Associate Director.
Brief Job Description ๅทฅไฝๆ่ฟฐ็ฎ่ฟฐ
ยท To establish and sustain a culture of regulatory compliance at Wuxi Supply Point that is proactive and professional that meets regulatory requirements, adds value and delivers a competitive advantage to the business.
ๅปบ็ซๅไฟๆๆณ่ง่ง่ไฝ็ณป๏ผไปฅ็ฌฆๅๆณ่ง่ฆๆฑใๅขๅ ไปทๅผๅนถไธบๅ ฌๅธไธๅกๆไพ็ซไบๆง็ไผๅฟใ
ยท Contribute to the QA function in developing / improving quality management system
ๅๅฉ่ดจ้้จๆน่ฟ่ดจ้็ฎก็ไฝ็ณป
ยท To provide coordination and oversight of functional quality & compliance and improve function ownership of Quality
้่ฟๅฏนๅ้จ้จ่ดจ้ๅๅ่งๆงๆไพ้ๅฝ็ๅ่ฐๅ็็ฃ๏ผๆ้ซๅ้จ้จ่ดจ้็ไธปไบบ็ฟๆ่ฏใ
Typical Accountabilities
ไธป่ฆ่่ดฃ
Quality systems management่ดจ้ไฝ็ณป็ฎก็
- Provide coordination and oversight of functional quality & compliance
ๅฏน้จ้จ่ดจ้ๅๅ่งๆงๆไพ้ๅฝ็ๅ่ฐๅ็็ฃ
- Lead and coordinate Quality key systems in place , including, but not limited, ็ป็ปๅๅ่ฐๅ ณ้ฎ่ดจ้ไฝ็ณป็่ฟ่ก๏ผๅ ๆฌ๏ผไฝไธ้ไบ๏ผ
โข GMP training GMPๅน่ฎญ
โข Document management ๆไปถ็ฎก็
โข QAA management่ดจ้ไฟ่ฏๅ่ฎฎ็็ฎก็
โข Change controlๅๆดๆงๅถ
โข Quality risk management ่ดจ้้ฃ้ฉ็ฎก็
โข Self-inspection่ชๆฃ
โข Complaint Management ๆ่ฏ็ฎก็
โข Management review ่ดจ้็ฎก็ๅ้กพ
- Continues improvement the quality system management with Lean tools
ๅฉ็จ็ฒพ็ๅทฅๅ ทๆ็ปญๆนๅ่ดจ้ไฝ็ณป็ฎก็
- Lead and support QAF/ site quality continuous improvement project
ไธปๅฏผ/ๆฏๆ่ดจ้้จ/ๅทฅๅๆ็ปญๆนๅ้กน็ฎ
- Maintain the good quality culture in site
็ปดๆคๅทฅๅ่ฏๅฅฝ็่ดจ้ๆๅ
Quality Compliance Routine่ดจ้ๆณ่ง่ง่ๆฅๅธธไบๅก
- Provide support on quality oversight on Non-PET business at Wuxi site, e.g. QC. E&SHE department, including change control, complex quality issue handling, validation etc.
ๅฏน้PET้จ้จ็ไธๅก๏ผๅฆQC๏ผๅทฅ็จ้จ็ญๆไพQAๆฏๆ๏ผๅ ๆฌๅๆด็ฎก็๏ผๅคๆ็่ดจ้ไบไปถๅค็๏ผ้ช่ฏๆดปๅจ็ญ
- Lead intelligence of external regulation, provide compliance advise when necessary
็ป็ปๅค้จๆณ่ง็่งฃ่ฏป่ฏไผฐ, ๅนถๅจ้่ฆ็ๆถๅๆไพๅ่ง่ฏไผฐๆ่ง
- Support different quality teams in QA function as SME when necessary
ๅฟ ่ฆๆถไฝไธบSMEๆฏๆๅทฅๅๅ่ดจ้ๅข้็ไธๅก
- Support investigation on QA/QC related issue
ๆฏๆQA/QC็ธๅ ณไบไปถ่ฐๆฅ
- Support 3PS & CMO affairs
ๆฏๆ3PSๅCMOไบๅก
- Coordinate and lead GMP inspection from internal/external
ๅ่ฐๅ็ป็ปๅ ๅค้จๅฏน็ไบงๅบๅฐ็GMPๅฎก่ฎกๅทฅไฝ
- Lead localization of global QCM to ensure comply with corporate quality system
็ป็ปๅ จ็QCM็ๆฌๅฐๅ๏ผ็กฎไฟๆฌๅฐๆต็จ่ฎพ่ฎก็ฌฆๅๅ จ็่ดจ้ไฝ็ณป่ฆๆฑ
- Maintain and improve PQS procedure and electronic system
็ปดๆคไผๅPQSๆต็จๅ็ธๅบ็็ตๅญๅ็ณป็ป
- Provide quality system related training, Coach and develop quality professional capability for QA function employees
ๆไพ่ดจ้็ณป็ป็ธๅ ณ็ๅน่ฎญ๏ผๆๅฏผๅๅๅฑ่ดจ้้จๅๅทฅ่ดจ้ไธไธ่ฝๅ
- Coordinate the communication with local healthy authority
ๅ่ฐๅๅฝๅฐ่ฏๆฟ้จ้จ็ๆฒ้
- Coordinate Site registration in China market.
ๅ่ฐไธญๅฝๅธๅบ็ๅทฅๅๆณจๅ็็ธๅ ณไบๅฎ
- Support CMCRA for site registration and product registration in global markets.
ๅๅฉCMCRAๅจๅฝๅคๅธๅบ็ๅทฅๅๆณจๅไปฅๅไบงๅๆณจๅ็็ธๅ ณไบๅฎ
- Support China RA for product registration in China market.
ๅๅฉๆณ่งไบๅก้จๅจไธญๅฝๅธๅบ็ไบงๅๆณจๅ็็ธๅ ณไบๅฎ
SHE ๅฎๅ จ็ฏๅขๅฅๅบท
Compliance with AZ code of conduct and SHE requirement
็ฌฆๅๅ ฌๅธ็่กไธบ่ง่ๅSHE็่ฆๆฑ
Education, Qualifications, Experience and Capabilities ๆ่ฒใ่ต่ดจใ็ป้ชๅ่ฝๅ
University graduate, major in pharmaceutical or related subjects
ๅคงๅญฆๆฏไธ๏ผ่ฏๅญฆๆ็ธๅ ณๅญฆ็ง
8 years of Quality working experience
8ๅนดไปฅไธ่ดจ้ๅทฅไฝ็ป้ช
Have work experience for a foreign pharmaceutical company
ๅถ่ฏๅคไผๅทฅไฝ็ป้ช
Cross Function working experience
่ทจ้จ้จๅทฅไฝ็ป้ช
Solid GMP and quality system management knowledge
่ฏๅฅฝ็GMPๅ่ดจ้ไฝ็ณป็ฎก็็ฅ่ฏ
Expert of quality management system and key process
่ดจ้็ฎก็ไฝ็ณปๅ ณ้ฎๆต็จไธๅฎถ
Knowledge of up-to-date technology and regulatory trend
ๅฏน่กไธๆๆฏๅๆณ่งๅ ทๆไธๆถไฟฑ่ฟ็่ฎค่ฏ
Expert of quality risk management
่ดจ้้ฃ้ฉ็ฎก็ไธๅฎถ
Knowledge of process control methodology and statistics, for example Ppk, FMEA
ๅ ทๅค่ฟ็จๆงๅถๆนๆณๅ็ป่ฎกๅญฆ็็ฅ่ฏ๏ผ็ฑปไผผPpk, FEMA็ญๅทฅๅ ท
Working knowledge of Microsoft applications, SAP or similar system
็ๆๅพฎ่ฝฏๅบ็จ๏ผSAPๆ็ฑปไผผ็ณป็ป
Good English่ฑ่ฏญๆฐดๅนณ่ฏๅฅฝ
Good Computer skill็ต่ไฝฟ็จ็็ป
Good communication skills
่ฏๅฅฝ็ๆฒ้ๆๅทง
Strong quality minds and service minds
ๅผบ็็่ดจ้่งๅฟตๅๆๅกๆ่ฏ
Date Posted
31-Aug-2026Closing Date
30-Dec-2026AstraZeneca 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.
How we rate this
PQS Associate Director at AstraZeneca rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.
Little AI. AI is not part of the work.
- โโโโ Builds AI80 to 100
- โโโโ Works on AI60 to 79
- โโโโ Uses AI40 to 59
- โโโโ Little AI0 to 39
Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.
Prepare for this job
Built from this posting and from similar jobs on Level.
Skills and AI tools this role asks for
Questions you could be asked
- Tell me about a project where quality management was part of your work. What did you do?
- Tell me about a project where gmp was part of your work. What did you do?
- Tell me about a project where quality assurance was part of your work. What did you do?
- Tell me about a project where compliance was part of your work. What did you do?
- Tell me about a project where auditing was part of your work. What did you do?
Adapt your resume
- List these exact terms on your resume: Quality Management, Gmp, Quality Assurance, Compliance, and Auditing. An applicant tracking system matches the wording, not the idea.
- Attach one line of real, concrete experience to at least one of them. A tool named with nothing behind it rarely survives a human read.
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