11 days old

Supply Chain Quality Cluster Lead South Asia

Tunas, MO 65764
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The role will be accountable for the implementation of and compliance to SCQ Global SOPs and any other Pfizer Quality Standard requirements. It will support the primary quality contact point for business partners internally (local and regional Regulatory, GSC, BU leads, Medical). It will be responsible for the management of the LCS and PCO Singapore, Thailand, Vietnam and Malaysia SCQ budgets and development and organisation of the team reporting into it. It will also be accountable for the supply of compliant product onto the Sinagpore, Thai, Vietnamese and Malaysian markets and availability of compliant product from LCS.

**1. Resolution of Product Quality Compliance Issues**

Deviation Management (in conjunction with the PGS Quality Operations) :

Approve all local deviation investigations and monitor CAPA effectiveness checks.

Product Complaint handling :

Ensure effective processes/resources are in place to meet all required complaint handling timelines and notification requirements.

**2. Notification to Management**

+ Informs SCQ Regional Lead of significant deviations and product complaints, as well as any issues impacting marketed product.

+ Provides support and advice for the PCO Quality Review teams under responsibility.

+ Supports the writing of AQRT Executive Summary for issues originating under the responsibility of the PCOs.

+ Attends Area Quality Review Teams (AQRT) meetings, where necessary to support the principal PCO representative.

+ Ensures the local implementation of actions identified during Area Quality Review Team (AQRT) meetings, e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions

**3. Product Quality System**

+ Confirm Global SOP compliance, completion of gap analysis reports and training

+ Monitor local SCQ performance (metrics) and identify and implement actions upon discovery of trends/issues and share with SCQ RL and relevant local stakeholders

+ Assess and communicate to SCQ RL and PCO leadership any new or updated regulatory requirements and adjust/enhance local systems and processes when required

+ Drive towards zero defects via continuous improvement of quality systems, procedures and processes

**4. Local Product Disposition**

+ Ensures effective and efficient local batch release.

**5.** **Inspections and Internal Audit**

+ Leads preparation for and co-ordination of GMP/GCP/GDP/MAH related inspections of PCO by Regulatory Authorities or Pfizer internal auditors

+ Prepare and agree with SCQ RL and applicable PCO colleagues on responses an action plans to address issues identified during regulatory inspections or Pfizer internal audits. **6. Local Contractor Quality Oversight (where managed by SCQ) *** Ensure effective quality oversight of local contractors (Logistic Service Providers, Re-labelers, re-packers and other contractors as applicable)Ensure quality agreements are maintained and reflect current requirementsReview quality performance and agree action plans to ensure continuous improvementCommunicate critical and major regulatory inspection observations and MSQA audit findings to SCQ RL and provide input into CAPA plans

**7. Quarantine Alert Notices (where non-Pfizer warehouses are used to receive and store product in the country)**

+ Ensures that Quarantine Alert Notices received are processed in a timely manner.

**8. Development and Maintenance of Consistent Quality Culture**

+ Reviews and reports on data and metrics on PCO quality performance and to PCO Management. This may involve a regular Management Quality Review process.

+ Provides ongoing education on Quality to relevant PCO functional groups, to increase awareness and understanding of requirements and enhance the Quality Culture

**9. Commitment Tracking**

Ensure Regulatory, Internal Audit and AQRT commitments are completed as required.

**10. Change Control**

Ensure all changes are appropriately documented, assessed by the relevant parties and approved as required.

**11. Market Actions**

Ensures the local market action team manages and completes all required market actions.

**12. Repackaging/Relabelling**

+ Ensures that all operations are performed in compliance with the relevant Global SOP

+ Approves the relevant forms for operations within scope of responsibility

**12. People Management**

+ Managing a team based in Singapore, Vietnam, Thailand and Malaysia and providing leadership, direction and development to Supply Chain Quality colleagues in the market.

+ Drive team engagement, and effective communication and development of direct reports by being available and present.

+ Supporting the development and execution of SCES Quality objectives.

+ Facilitate development and execution of objectives consistent with SCESQ Goals and strategies.

+ Supporting the recruitment, training and development of Supply Chain quality colleagues.

+ Follow-up on delegated tasks to ensure they are completed and that appropriate decisions are made in the process

+ Annual discussion regarding talent in country with the SCQ RL, succession planning and high performers

+ Provides technical and functional leadership to the teams under the scope of responsibility

**13. Financial**

+ With the Regional Director, SCQ Asia Pacific prepares budgets for the forthcoming year

+ Manages the current budget to ensure the budget is met with no unfavourable variance

+ Investigates cost saving initiatives within SCQ business, and reports on the contribution of the team to those savings

**14. Drive Stakeholder Value**

+ Represent Quality Operations at relevant above market forums.

+ Provide Quality Operations input into projects, on-boarding of new contractors, new systems, business deals and new product launches

**15. Innovation and Continuous Improvement**

+ With direct reports identifies Method 1 (Yellow Belt) projects for completion annually

+ Shares best practice opportunities with the teams

+ Instills an innovative mindset within the team

Reviews team metrics and identifies opportunities for improvement

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

Quality Assurance and Control
Posted: 2020-03-18 Expires: 2020-04-18

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Supply Chain Quality Cluster Lead South Asia

Tunas, MO 65764

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