Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard.
What You Will Achieve
In this role, you will:
- Be responsible for the application, maintenance, update and renewal of the site Drug Manufacturing License, organize relevant document preparation, internal review, system submission and regulatory communication, and ensure that changes to licensed items and registered items on the license are applied for and updated in a timely manner in accordance with regulatory requirements.
- Be responsible for monitoring, identifying, interpreting and communicating laws, regulations, rules, the Chinese Pharmacopoeia and relevant guidelines issued by Chinese drug regulatory authorities; organize applicability assessments and gap analyses; drive and track the development and completion of remediation actions; and ensure that relevant regulatory requirements and national drug standards are effectively implemented at Wuxi site.
- Act as Local Process Owner (LPO) for Pfizer Quality System processes in compliance area, support communication, assessment and implementation of quality system requirements at Wuxi site, and be responsible for local deployment and execution of relevant processes.
- Support BoH GMP inspection-related activities, including inspection preparation, document coordination, on-site support, issue clarification, drafting inspection responses, cross-functional communication and follow-up of inspection-related actions, to ensure inspection management and subsequent remediation comply with Pfizer Quality System and regulatory requirements.
- Act as site internal audit coordinator to coordinate the planning, preparation, execution, response drafting and follow-up action tracking of internal audits at Wuxi site, and drive cross-functional teams to complete assessment, responses and remediation actions for audit observations.
- Be responsible for material supplier management to ensure supplier management complies with GMP and relevant regulatory requirements.
- Assist Regulatory Affairs and China CMC team in new product registration, re-registration and post-approval change management, and support the preparation and review of relevant quality documents, site compliance information, license information and regulatory response materials.
- Be responsible for Annual Product Reports(APRs) activities, including annual report planning, cross-functional information collection, document review, report preparation/submission coordination and follow-up of subsequent questions, to ensure annual drug reports are completed in a timely and accurate manner in accordance with regulatory requirements.
- Be responsible for coordinating the implementation of quality management review at Wuxi site, including collection of review input materials, consolidation of quality metrics and trend information, meeting organization support, review outputs and follow-up of related actions.
- Be responsible for site-wide communication, training and promotion of data integrity, and support data integrity risk identification, gap assessment, remediation action tracking and continuous maintenance of good data integrity culture.
- Complete other related work assigned by Site Compliance Lead.
Here Is What You Need (Minimum Requirements)
- Bachelor’s degree or above with at least 2 years of drug quality-related experience, majoring in pharmacy, pharmaceutical engineering, biopharmaceuticals, chemistry or a related field.
- Pharmaceutical professional knowledge and China GMP knowledge, with familiarity with drug manufacturing quality management requirements.
- Good English reading and writing skills, verbal communication and strong document writing capability.
Bonus Points If You Have (Preferred Requirements)
- Experience in quality management, GMP compliance, regulatory affairs, government inspections/internal audits, supplier quality management or registration support in a pharmaceutical manufacturing enterprise is preferred.
- Excellent interpersonal skills and the ability to communicate effectively with colleagues at all levels.
- Cross-functional coordination capability, analytical judgment and problem-solving capability.
- Adaptability and willingness to continuously learn new techniques and new regulations.
- Good time management and multitasking capabilities, as well as good teamwork spirit, sense of responsibility and compliance awareness.
- Strong knowledge of lean manufacturing principles, six sigma methodologies, and statistical analysis
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Quality Assurance and Control