Pfizer Jobs

Supply Operation Quality Supervisor-Shanghai/Suzhou

Pfizer

Supply Operation Quality Supervisor-Shanghai/Suzhou

Posted Yesterday

Be an Early Applicant

2 Locations

In-Office

Senior level

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical

We’re in relentless pursuit of breakthroughs that change patients’ lives.

The Role

Lead and execute quality assurance, inspections, supplier quality, and local product disposition for PCO operations. Manage QMS activities, audits/inspections, deviations/CAPAs, product release, quarantine handling, complaint triage, and regulatory reporting. Support GxP supplier oversight, training, and quality risk management while developing team quality culture and ensuring compliance with local GSP and regulatory requirements.

Summary Generated by Built In

1、Quality Assurance & Inspections and Internal Audit

Assists with the timely implementation of applicable quality management systems (SOPs) within the PCO.
Assists with ensuring initial and continuoustraining programs are implemented and maintained for all relevant PCO colleagues.
Ensures planned, permanent & temporary changes of GMP/GDP related activities & systems are managed & documented appropriately. Ensures change actions are completed as per agreed timelines.
Collects key quality performance indicators, evaluates and highlights any significant trends and identifies actions.
Monitor Key Performance Indicators (KPIs) of the QMS, evaluate and highlight significant trends, and identify actions. Leads and/or participates in Quality Review Meetings as required.
Provides support in the preparation and coordination of any Health Authority (HA) inspection and/or internal Pfizer audits of GMP/GDP activities in the PCO.
Work with local cross functional team to define appropriate action plans to address the inspection/audit observation and tracks action implementation within the agreed timelines.
Participates in the self-inspection program as an auditor and/or auditee, as required.
Leads and/or participates in the Quality Risk Management program for the consistent application, documentation and communication of risks to product quality/patient safety in support of GxP activities under the remit of SOQ.

2、Local Product Disposition & Resolution of Product Quality

Perform the local release process of Products under the PCOs distribution license, as required.
Supports the coordination of all Product repackaging and/or relabeling activities in the PCO and at the third-party packaging site. Review and approve documentation related to the repackaging and/or relabeling of Pfizer Product, as required.
Actions Quarantine Alert Notifications promptly, as needed.
Ensures quarantine shipments are managed compliantly according to procedures, as required.
Provides support for any market action operation in the PCO, as required.
Complaint Handling - Perform Intake and Triage, issue correspondence letter as required. Acts as a contact point for Regulatory Agency/reporter in the PCO, as required.
Lead and/or participate in deviation investigations using appropriate tools and works with cross-functional teams to implement CAPAs.
Notify Management of significant concerns or deviations within the QMS which have the potential to impact product, regardless of release status. Where issues originate in the PCO, assist with the preparation of QRT meetings, where required. Assist with the implementation of local actions identified during QRT.
Management of relevant corrective and preventative actions (CAPA)

3、Supplier Quality Management

Execute tasks associated with the management of GxP Suppliers including qualification, quality oversight in accordance with internal and regulatory requirements for GxP activities.
Assists with ensuring appropriate customer screening processes are in place to align with Pfizer and local regulations, as required.
Assist with the coordination of RQA audits at the Supplier.

4、Leadership Skills

Facilitate development and execution of objectives / projects consistent with SOQ Purpose Blueprint.
Development and Maintenance of Quality culture, within the team and organization.

5、Local Requirements

Responsible for operation under GSP license.
Responsible for IDC importation testing/surveillance testing.
Responsible for Annual Product Report/Annual Product Quality Review Report completion as needed for regulation requirements.
Support other required from local regulations.

Here Is What You Need (Minimum Requirements)

A minimum Tertiary Education in Science, Pharmacy or related discipline.
A minimum of 5 years in the pharmaceutical industry in a quality role
Demonstrated ability to influence, when necessary, particularly with stakeholders and external parties.
Experience in GSP and QMS.
Technical writing and reporting
Licensed Pharmacist is preferred
Fluent in English (written & verbal)

Bonus Points If You Have (Preferred Requirements)

Experience in quality administered systems
Strong organizational skills and attention to detail
Experience with regulatory compliance and documentation
Ability to mentor and review the work of other colleagues
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

Skills Required

Tertiary education in Science, Pharmacy or related discipline
Minimum 5 years in the pharmaceutical industry in a quality role
Demonstrated ability to influence stakeholders and external parties
Experience in GSP and QMS
Technical writing and reporting
Fluent in English (written & verbal)
Licensed Pharmacist
Experience in quality administered systems
Strong organizational skills and attention to detail
Experience with regulatory compliance and documentation
Ability to mentor and review the work of other colleagues
Experience using AI tools such as ChatGPT or Microsoft Copilot

What the Team is Saying

View all jobs at Pfizer

View Pfizer Profile

Report Job

Am I A Good Fit?

beta

Get Personalized Job Insights.

Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company

HQ: New York, NY

121,990 Employees

Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.