The role of the Supply Chain Quality Operation Manager (SCQ Manager) is to establish and maintain an appropriate Product Quality System and Quality Culture at Pfizer Country Office (Panama), Logistic Service Provider (LSP) and other vendors, , in order to ensure compliance with Pfizer and Regulatory Authority expectations.
The SCQO Manager reports solid line to SCQ Cluster Lead.
Provide strategic Quality leadership and programs to the contracted Logistics Service Providers to ensure that the required Pfizer and regulatory quality and compliance standards and guidance are implemented and are sustainable.
Overall responsible for the design, implementation, execution, monitoring, and compliance of the Quality Systems within the Pfizer Logistics and Supply Network in the LSP.
Provide Quality Unit oversight at contracted Logistic Service Provider in Panama. Proactively partners with operations in ensuring that all distribution operations are in compliance with cGMP’s, Regulatory standards and Pfizer Policy.
In addition, SCQ Manager will be the main point of contact for the investigation and resolution of all product quality issues discovered or originating in the Contractor (LSP, Printer Supplier), Pfizer Country Office (Panama) and for interacting with the relevant local stakeholders (such as Regulatory Affairs, GSC, BU) and PGS on such issues.
Also, the SCQ Manager will monitor the product quality and compliance activities to ensure current regulatory expectations are met, and facilitate internal and regulatory GMP inspections.
Ensures full compliance of the Panama LSP with government and Pfizer policies, procedures, guidelines and regulations
Accountable for the robustness of the quality systems within Panama LSP. This includes :
Assures the investigations, corrective / preventative actions and commitments systems are in compliance with internal and industry standards
Ensure QA review / approval of all GMP related documents are performed to ensure good documentation practices are consistently executed
Local Contractor Quality Oversight
LSP & Printers
Develops, support and maintains up to date Quality Agreements with GMP / GDP contractors involved in the manufacture, repackaging as well as other activities at Logistics Service Providers.
Oversees quality operations at contractors, which includes but is not limited to :
Contractor Assessment and Approval : ensures all GMP / GDP contractors have been formally assessed and approved.
Qualification on Validated Pfizer System (SMS).
Deviation Management : evaluates the impact of all significant deviations affecting Safety, Identity, Strength, Purity & Quality (SISPQ), generated at the contractor and agrees corrective actions.
If necessary, initiates the Notification to Management process.
Quality System Support : Assess contractor quality systems, review quality performance and agree action plans to ensure continuous improvement.
Include quality reviews during Business Review Meeting (BRM), where in place.
Issue and review Metrics : Periodically assess the overall quality risk associated to the contractor. Act on adverse trends in order to improve contractor quality and compliance performance.
Facilitates the Pfizer Manufacturing Supplier Quality Assessment (MSQA) audit process at the contractor. Helps to define appropriate action plans for improvement and follow-
up and communicate action closures.
Resolution of Product Quality Compliance Issues
Deviation Management Investigates, together with appropriate local functions, deviations from Product Quality and Compliance requirements that occur within the responsibility of the contractors, IO LALC, PCO Panama and tracks preventive / corrective actions.
Local investigations may relate to product damage, artwork and labeling errors, counterfeits, temperature excursions during transport or issues with contract manufacturers or logistics service providers etc.
Provide trends and updates to PCO leadership
Product Complaint handling :
Manages the intake of complaints from the LSP.
Tracks complaint responses and resolutions on PCOM (apply to LSP)
Develops and issues responses to complainants in a timely manner.
Notification to Management
Notifies SCMQO Management of significant deviations and complaints.
Attends Area Quality Review Teams (AQRT) meetings, to provide the local perspective on the issue at hand. Provides AQRT Executive Summary for issues originating under the responsibility of the Contractors or SCMQO Panama Quality System.
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
Participate in Rapid Response Teams meetings and follow to completion actions.
Coordinate process for Market actions and follow to completion.
Product Quality System
Ensures timely implementation of all applicable Product Quality SOPs (issued by SCQ) within the PCO (Panama).
Ensures that all relevant PCO (Panama)colleagues are appropriately trained in the Product Quality SOPs
Monitors key quality performance indicators, evaluates and highlights any significant trends and identifies actions.
Conducts internal assessments to assess compliance with product quality systems & processes, and to identify improvement opportunities.
Assess new quality system / local regulatory requirements and adjusts / enhances local systems and processes when required.
Ensure applicable global systems are deployed timely and sustain (sQTS applications i.e. trackwise modules
Provide direction to PCO business initiatives to ensure Pfizer Quality Standard are followed in commercial agreements within Pfizer and with external Pfizer partners.
Local Product Disposition
Accountable for Product Quality Release to the CAC Markets;Assures processes and controls are in place to comply with the distribution of regulatory approved product to the CAC Markets.
Ensures product reconditioning is performed complying with Pfizer procedures, guideless, GMP and regulations.Oversight of local release for imported products, reconditioned products and packaging materials in compliance with the applicable local regulations and local procedures, prior to distribution / sale within country.
Defines requirements under which returns can be taken back to saleable stock and supports local actions, in cooperation with logistics and distribution center.
Administrate material status within the distribution network. This includes :
Coordinate the inspection of products entering the Logistics Center, in accordance with the requirements of GSCPM.
Ensure that products comply with the current release technical documentation.
Ensure compliance and disposition of products according to existing arts, regulatory and quality requirements.
Inspections of product and materials to approved specifications and provide final disposition status.
Technical Specification sheets, for approval of reconditioning instruction to LSP.
Responsible for leading or assisting in root cause investigation in the event of a non-conformance, related to any of the regulatory areas described above in the position summary via the utilization of Operational Excellence methodologies / tools.
Present formal notifications of significant issues to senior management and Quality Review Teams.
Inspections and Internal Audit
Leads preparation and coordination of Regulatory Agency and internal Pfizer inspections of Product Quality and Compliance (GMP / GDP) activities at the PCO.
Works with local functions to define an appropriate action plan to address the inspection / audit observation
Tracks the implementation of the identified actions within agreed timeframes
Development and Maintenance of Consistent Quality Culture
Collects data and metrics on PCO and LSP quality performance and communicates this 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
PGS Global Quality Operations
Provides support to the CAC Quality Operations Department with the implementation, performance and monitoring of GMP / GDP Quality Systems and compliance related initiatives within the Logistic Center.
SUMMARY OF SKILLS
Has an appropriate education in science or quality topics.
Has experience in Quality Systems in a Biopharmaceutical environment
Has Logistic Service Provider (LSP) and vendors quality oversight experience
Has appropriate quality and technical experience to management expectations
Makes sound and effective quality decisions under pressure.
Diplomatic in communication with internal and external customers.
Show strong negotiation and effective communication skills. Is influential
Self-motivated individual who is comfortable with working independently
Experience to lead a team
Able to lead and work effectively in cross-functional team & collaborate
Advance English language communication verbal and written
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.