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AstraZeneca

Global pharmaceutical company developing prescription medicines

PQS Associate Director

Regulatory & Quality (Life Sciences)Posted on Nov 3
Full-timeWuxi, Jiangsu, ChinaNo salary listedIn-person

About the Job

Requirements

  • A university degree in pharmaceutical or related subjects is required.
  • At least 8 years of quality work experience is required.
  • Work experience at a foreign pharmaceutical company is required.
  • Cross-functional work experience is required.
  • Solid knowledge of Good Manufacturing Practice (GMP) and quality system management is required.
  • Expertise in quality management systems and key processes is required.
  • Knowledge of current technology and regulatory trends is required.
  • Expertise in quality risk management is required.
  • Knowledge of process control methodology and statistics, such as Ppk and FMEA, is required.
  • Working knowledge of Microsoft applications and SAP or a similar system is required.
  • Good English proficiency is required.
  • Computer skills are required.
  • Good communication skills are required.
  • Strong quality and service orientation are required.

Responsibilities

  • Establish and sustain a proactive, professional regulatory compliance culture at the Wuxi Supply Point that meets regulatory requirements, adds business value, and delivers competitive advantage.
  • Contribute to developing and improving the quality management system within the QA function.
  • Coordinate and oversee functional quality and compliance, and improve functional ownership of Quality.
  • Lead and coordinate key Quality systems, including GMP training, document management, QAA management, change control, quality risk management, self-inspection, complaint management, and management review.
  • Continuously improve quality system management using Lean tools.
  • Lead and support quality function and site continuous improvement projects.
  • Maintain a strong quality culture at the site.
  • Provide quality oversight support for non-PET business at the Wuxi site, including QC and E&SHE departments, covering change control, complex quality issues, and validation.
  • Monitor and interpret external regulations and provide compliance advice when needed.
  • Serve as a subject matter expert supporting quality teams in the QA function when needed.
  • Support investigations of QA- and QC-related issues.
  • Support 3PS and CMO affairs.
  • Coordinate and lead internal and external GMP inspections of the manufacturing site.
  • Lead localization of global QCM to ensure compliance with the corporate quality system.
  • Maintain and improve PQS procedures and the corresponding electronic system.
  • Provide quality system training and coach and develop the quality capabilities of QA function employees.
  • Coordinate communications with the local health authority.
  • Coordinate site registration in the China market.
  • Support CMCRA with site and product registration in global markets.
  • Support China RA with product registration in the China market.
  • Comply with the AstraZeneca code of conduct and safety, health, and environment requirements.

About the Company

AstraZeneca

Global pharmaceutical company developing prescription medicines

AstraZeneca develops and markets prescription medicines and vaccines worldwide, with a focus on oncology, cardiovascular/metabolic, respiratory, and infectious diseases. Its products work by targeting specific biological pathways or cells, using small-molecule therapies, biologics, and vaccines to treat diseases or prevent infections. It differentiates itself through its dual heritage from Sweden and the UK, a broad pipeline, and strong R&D and collaborations that move from discovery to patient access. Its goal is to improve people’s health by discovering, developing, and delivering medicines and vaccines to patients worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Cambridge, United Kingdom
Founded
1913

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