Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.  Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

The SCMOQ Manager is responsible for Quality Management Operation, System and Compliance activities in South Asia Cluster (Vietnam, Thailand, Myanmar, Cambodia, Laos, Malaysia, Brunei, Singapore, Indonesia), to maintain an appropriate and sustainable Product Quality System and inspection readiness at the Pfizer Country Office (PCO) in order to ensure compliance with Pfizer, GMP/GDP and Regulatory Authority expectations. 

Issues resolution related to Market Product Disposition

• Lead and review investigation performed by internal and external business partners on the resolution of deviations related to the release of Pfizer products in compliance with the applicable local regulations and local procedures, prior to sale within the country.
• Performs local release of imported products and evaluation of returned goods of the assigned market (where applicable), in compliance with the applicable local regulations and local procedures, prior to sale within country.

Product Complaint management

• Support the intake of PCO product complaints of the assigned markets in a timely manner, tracks complaint responses.

Deviation Management

• Lead cross-functional investigation team for deviations that occur within the responsibility of SCMOQ organization, agrees and tracks corrective/preventive actions.
• Monitor CAPA effectiveness checks.

Repackaging and Relabeling

• Evaluate and Approve the relevant Repackaging and Relabeling request forms for operations within scope of responsibility.

Notification to Management

• Informs SCMOQ Cluster Lead of significant deviations and complaints as well as any issues impacting marketed product within the required timeframes.
• If required, attends Area Quality Review Teams (AQRT) meetings together with Market PCO representative, to provide local perspective on the issue. Provides AQRT Executive Summary for issues of the assigned products originating under the responsibility of the PCO.       
• Oversight of Market Actions in the Cluster, coordinate with the Market SCMOQ leads in management of significant issues and local market actions i.e. recall, communication with Regulatory Agency, local corrective/preventive actions

Product Quality System Compliance

• Lead quality compliance driven initiatives that address GMP/GDP issues, and result in improved business performance, operational processes within the Cluster.
• Lead the collection, review and analyze data and metrics on PCO quality performance
• Coordinate Cluster operation KPI reviews, Escalation meeting and Management Quality Reviews
• Lead compliance assessments of product quality systems & processes.    
• Lead process improvement projects and forums
• Lead or participate in risk assessment and apply Quality Risk Assessment tools as necessary.
• Support Market SCQ leads in the assessment of new quality system/local regulatory requirements and adjusts/enhances local quality systems and processes, when required. 
• Support management of Quality Systems such as Commitment Tracking. Ensure timely completion of actions.

External Inspections and Internal Audit

• Responsible for Overall Inspection Readiness of SCMOQ at the Cluster
• Lead Site Self Inspection for SCMOQ scope of activities, issue Self Inspection report and agree the Corrective/Preventive actions with the auditee.
• Support the Market SCQ leads with the preparation of GMP/GDP related inspections of PCO by Regulatory Authorities or internal auditors.
• Support the Market SCQ leads on responses and action plans to address issues identified during GMP/GDP related regulatory inspections or internal audits.

Local Contractor Quality Oversight (where managed by SCMOQ)

• Contractor Assessment and Approval: ensure all GxP contractors assigned (including suppliers & service providers) have been formally assessed and approved.

Development and Maintenance of Consistent Quality Culture

• Provides ongoing education on Quality, to increase awareness and understanding of requirements and enhance the Quality Culture.

Drive Stakeholder Value

• Represent SCMOQ Quality Operations at the forums.
• Provide Quality Operations input into projects, on-boarding of new contractors, new systems, business deals and new product launches.

Qualification and Experience (must have)

• A minimum of 7 years in the Quality role in the pharmaceutical industry is a must.
• Prior experience in Commercial Quality at the capacity of a Quality Manager
• Qualified certified Quality auditor
• Demonstrated sound knowledge, solid experience and application in Quality Management system and Continuous Improvement.
• Demonstrated sound knowledge of current Good Manufacturing Practice/ Good Distribution Practice
• Demonstrated sound quality knowledge and solid experience and application with current Good Manufacturing Practice/ Good Distribution Practice.
• Ability to influence, when necessary, particularly with stakeholders and external parties.
• Ability to communicate across all levels of the organization and also use communication to demonstrate the value of the quality organization.
• Ability to interpret and analyze data with strong problem-solving skills to provide and support sound rationale to drive decision making.
• Ability to act decisively.
• Ability to challenge and see views from different perspective.
• Ability to navigate complex situations.
• Knowledge of business acumen
• Fluent in English (business), strong presentation skill and professional quality report writing skills.  

 
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Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.