15 days old

Senior Manager Supply Chain Quality Algeria

Pfizer
الدار البيضاء, الجزائر
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**ROLE PURPOSE**

The Incumbent assumes to the role of the Responsible Person for 'Organization' and oversees all wholesale-related activities with the responsibility to



+ establish and maintain a Quality Management System and a Quality Culture within 'Organization' in compliance with internal and Regulatory Authority expectations.

+ manage product quality and compliance activities in 'Organization' in line with current regulatory requirements,

+ facilitate internal and regulatory GDP inspections.

+ track quality metrics, assess risks and implement actions to continuously improve performance

+ engage with 'Organization's and functional Management to obtain and maintain alignment and support for SCQ and compliance activities



**KEY ACCOUNTABILITIES**



**Resolution of Product Quality and Compliance Issues**

Deviation Management in conjunction with the PGS Quality Operations:

Investigates, together with appropriate local functions, deviations from Product Quality and Compliance requirements that occur within the responsibility of the 'Organization' and agrees 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.

Customer Complaints handling:

Ensures that customer complaints on product quality are dealt with effectively.

Performs intake and triage of product quality complaints from customers, assignment of class and criticality to each case and forwarding to the appropriate investigating Site via the global complaints management system.

Tracks investigation results and issues responses to complainants in a timely manner, if requested.

Provides input from a quality perspective to Business Functions for the resolution of customer complaints related to distribution activities.



Notification to Management:

Informs Quality Operations Management of significant deviations and complaints.

Attends Area Quality Review Teams (AQRT) meetings, as responsible 'Organization' representative and provides the 'Organization' specific perspective on the issue at hand. Provides AQRT Executive Summary Report for issues originating under the responsibility of 'Organization'.

Ensures the local implementation of actions identified during AQRT meetings, e.g. recalls, communication with the national Regulatory Agency, local corrective/preventive actions.



**Quality Management System**

Ensures timely implementation of all applicable Product Quality SOPs within the area of responsibility.

Implements and maintains a GDP conform onboarding and training plan for personnel in the 'Organization'.

Monitors key quality performance indicators, evaluates and highlights any significant trends and identifies actions.

Ensures that self-inspections are performed at appropriate regular intervals following a pre-arranged programme and necessary corrective measures are put in place.

Monitors and assesses new quality system/local regulatory requirements and adjusts/enhances local systems and processes when required. Notifies local and functional management about relevant changes.

Ensures that any additional national legal requirements imposed on certain products or activities are adhered to.

Keeps appropriate records of any internally or externally delegated duties.



**Product Disposition** Ensures local release of products under 'Organization' control in the markets, in compliance with the applicable local regulations and local procedures, prior to distribution/sale within country.

Ensures and documents control of product certificates and transportation / temperature records obtained from product's transportation for replenishment.

Decides on the final disposition of returned, rejected, recalled or falsified products.

Defines requirements under which returns can be taken back to saleable stock and supports local actions, in cooperation with other functions, including the logistics and distribution center.

Coordinates and promptly performs any recall operations for medicinal products.

Initiates the required internal actions if counterfeit products are identified and information to the regulatory body, as required.



**Inspections and Internal Audit**

Leads preparation and coordination of Regulatory Agency inspections and internal audits of Product Quality and Compliance (GMP/GDP) activities. Works with local functions to define an appropriate action plan to address inspection/audit observations.

Tracks the implementation of the identified actions within agreed timeframes.



**Subcontracted activities with GMP/GDP impact**

Approves any subcontracted activities which may have an impact on GMP/GDP: develops, negotiates and maintains up-to-date Quality Agreements with GMP/GDP contractors, including but not limited to Transportation and Logistics Service Providers (LSPs) as well as relabeling/repackaging contractors.

Oversees quality operations at contractors in accordance with internal and regulatory requirements , including:

Contractor assessment and approval: ensures all GMP/GDP contractors have been formally assessed and approved.

Deviation Management: overlooks the evaluation and the impact of all significant deviations affecting safety, identity, strength, purity and quality, generated at the contractor and agrees corrective actions. If necessary, initiates the "Notification to Management" process.

Quality System Support: estabishes and maintains a personal contact with relevant contractor representatives including the Responsible or Qualified Person to regularly review and assess quality systems, quality performance and agree action plans to ensure continuous improvement.

Issue and review metrics: periodically assesses the overall quality risk associated to the contractor. Acts on adverse trends in order to improve contractor quality and compliance performance.

Facilitates the Corporations internal audit-functions audit process at the contractor. Helps to define action plans for improvement and follow-up and communicate action closures.



**Quarantine Alert Notices**

Receives and manages Quarantine Alert Notices for products in the Corporation's Portfolio. .

Establishes if product lots are held by an LSP and, if so, alerts the LSP to place the product on hold.

Ensures information to the internal coordinating function of product quantity still within the 'Organization's' control and implementation of product disposition decision.



**Oversight of local Relabeling and Repackaging Operations**

Ensures relabeling/repackaging contractor has been internally assessed and approved.

Overlooks the process to be performed in accordance with internal and GMP requirements.

Assertains regulatory approval of the relabeling/repackaging activity has been obtained.

Coordinates activities related to Pfizer products at the relabeling/repackaging contractor.



**Development and Maintenance of Consistent Quality Culture**



+ Collects data and metrics the local and regional quality performance and communicates this to local and functional Management, e.g. by a regular Management Quality Review process.

+ Provides ongoing education on Quality to relevant local and regional functional groups, to increase awareness and understanding of requirements and enhance the Quality Culture in the local setting.



**Suppliers' and Customers' Qualification**



+ Ensures that suppliers and customers are qualified in accordance with local and GDP-requirements.



**Pharmacovigilance and the compliance to rules and ethics codes**



+ Completes in due time the "Your Reporting Responsibilities: Monitoring the Safety, Performance, and Quality of Pfizer Products" (YRR) training program and the annual re-training.

+ Reports information regarding drugs' safety to the local Drug Safety Unit, in compliance with the YRR training materials.

+ Has knowledge of and reliably applies all Compliance and Business Ethics rules.

+ Reports any violation of the Compliance and Business Ethics rules to the manager or the Corporation's Ombudsman.



**Personel Managerial Responsibilities**



+ Provide oversight and direction to direct reports

+ Ensure recruitment of qualified personel, new employee onboarding and development of staff including Individual Development Plans in place

+ Lead and empower team members, delegate tasks and responsibilities as appropriate, ensure regular feedback.

+ Create a culture of team spirit and trust, fostering the OWNIT and Dare to Try attitude in line with the principles and vision of the corporaiton



**Personal development through**



+ Actively participates in 'Organization's' trainings, assignments, projects.

+ Participates in and contributes to relevant Pfizer internal and external meetings, i ncliding commercial events.

+ Identifies personal adevelopment opportunities and engages to grow and improve.

+ Maintains a good work-life balance.



**REQUIRED SKILL SET**



+ **Technical**



+ Has a pharmaceutical degree or. Should be a Pharmacist

+ Eligibility for the position of a Technical Director in accordance with the requirements in Algeria

+ Has appropriate technical and quality experience to management expectations.

+ Makes sound and effective quality decisions under pressure.

+ Computer literate

+ Fluent English communication skills - verbal and written



+ **Managerial**



+ Leadership traits, able to engage and motivate

+ Strong negotiation and effective communication and influencing skills.

+ Self-motivated, comfortable to work independently

+ Aware of and able to navigate cross-cultural differences

+ Able to lead and work effectively in cross-functional teams



+ **Experience**

+ 7 to 10 years of relevant experience in the pharmaceutical industry



**\#LI-PFE**



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: 2020-10-13 Expires: 2020-11-13
Sponsored by:
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Senior Manager Supply Chain Quality Algeria

Pfizer
الدار البيضاء, الجزائر

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