Supply Chain Quality Algeria Lead

Job Description

Supply Chain Quality Market LeadOrganization overviewThe key role of Pfizer SCQ is to establish and maintain an appropriate and sustainable Product Quality System and Quality Culture within Pizer Country Office, any contractor related to GMP/GDP activities and Pfizer Owned DC, so that compliance with Pfizer and Regulatory authority expectations and protection of Pfizer patients/customers from any product quality risk are ensured.Role description and Main responsibilitiesMaintenance of the compliance to the local BOH regulations-Coordinate the product quality and compliance activities at the PCOs, to ensure current BOH expectations are met.-Act as the Qualified / responsible Person to local authorities or support Qualified Person activities for all Pfizer Product Quality Compliance issues in the market.Governance & internal organization

• Responsible for the timely implementation of all applicable GSOPs within the PCO and DC
• Ensure SCQs and all relevant PCO /DC colleagues are appropriately trained in the Product Quality SOPs.
• Lead PCO /DC Quality Review team to ensure cross-functional input into issues.
• Monitor KPIs, analyze collected metrics, evaluate and highlight any significant trends and identify actions. Ensure metrics are tracked in the global system.
• Accountable for completion of internal assessments to ensure compliance with product quality systems and processes and to identify improvement opportunities.
• Accountable for the assessment of new or proposed quality system/local regulatory requirements and adjusts/enhances local systems and processes when required.
• Commitment Tracking management
• Change Control Management

• Inspection and Internal Audit

• Lead preparation and coordination of GMP/GCP/GDP/MAH related inspections of PCO Pfizer /DC internal/MSQA audits

Product quality assurance & operations Notification to Management

• Notifies Cluster Lead and SCQ Regional Lead of significant product quality and compliance issues.
• Attend AQRT meetings, as PCO /DC representative, to provide the local perspective on the issue at hand.
• Provide AQRT Executive Summary for issues originating under the responsibility of the PCO.
• Ensure the local implementation of actions identified during AQRT meetings

• Deviation and CAPA Management

• Approve investigation of product quality incidents that occur within the responsibility of Pfizer country office /DC in cooperation with the relevant internal/external functions.
• Track the preventive and corrective actions until completion within the set due dates.
• Accountable to ensure that all SCQ or related GMP/GDPs deviations are handled according to Pfizer SOP and local requirements.

• Product Complaint Handling

• Manage the intake and triage of complaints from the markets under PCO responsibility

• Local Product Disposition

• Accountable for timely local release of imported products, in compliance with the applicable local regulations and local procedures prior to distribution sale in the country.

• Oversight of local repackaging/relabeling operations

• Market returns

• Accountable to define requirements under which returns can be taken back to saleable stock and supports local actions in cooperation with Logistics and Distribution Centers.

• Quarantine Alert Notices managements

• Market Action

• Leading the market Action committee in Pfizer PCO.

Development and Maintenance of Consistent Quality Culture

• Align SCQ team and stakeholders by ensuring ongoing Quality education and trainings to increase awareness and understanding of requirements and enhance the quality culture within Pfizer PCO/DC.
• own/Participate in regular meetings with PCO/DC LT .

LSP / Contractor management & oversight

• Ensure all GMP/GDP contractors have been formally assessed ad approved.
• Facilitate RQA Audit process of contractors and LSPs
• Agree with contractors/LSPs on action plans to address observations noted during the audits or regular visits and Ensures implementation of CAPA plans.
• Ensure regular quality management review for continuous improvement.

Quality agreements

• Ensure quality agreements are maintained and up to date with GMP/GDP contractors involved in manufacturing, repackaging, laboratory testing or activities at LSPs.

People Management

• Proactively manage the team member to ensure accurate/consistent/timely feedback is provided by ensuring monthly (and as needed) 1:1 meeting
• Monitor the performance of the team member and ensure the implementation of the individual development plan and the talent plan succession
• Provides technical and functional leadership to the teams under the scope of responsibility.

Market Business & global Support

• Actively participate in market forum as spokesperson on quality topics.
• Foster and grow departmental communications and networking to assist with the quality reviews and crises management.
• Participates in business initiatives giving advice and assessing the impact to product quality and compliance.
• Ensure effective communication and collaboration with Pfizer (PCO/affiliate) internal stakeholders to ensure alignment and optimal support, launches and continuous availability of quality compliant Pfizer products.
• Work closely with other platform lines to achieve process development and improvements as ONE Pfizer.

Budget Management

• Manage the SCQ team expenditure and resources.
• Align SCQ team into a budget saving strategy

QualificationsMust-Have

• Bachelors Degree
• 7+ years experience
• Demonstrated experience leading successful team
• Diverse leadership experiences and capabilities including ability to influence and collaborate with peers, develop and coach others, and create business impact
• Detailed knowledge of clinical trial operational processes and supporting systems and tools
• Finance awareness and ability to develop training budget estimates and justify costs
• Strong project management, organization and planning skills
• Strong written and verbal communication skills
• English fluent

Nice-to-Have

• Masters degree
• Relevant pharmaceutical experience
• Project management and continuous improvement experience

Work Location Assignment:Flexible#LI-PFEPfizer 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#LI-PFE

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