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Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Cairo, Egypt

Job Description:

J&J MedTech is recruiting for a Commercial Quality Senior Specialist MEA reporting to the Manager Commercial Quality and to be based in Cairo, Egypt.

Job summary

The position is accountable for the oversight and execution of Quality Management Systems and compliance for Commercial Quality MedTech MEA.

The position serves as a local point of contact on Quality related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues.

The position implements departmental strategies and services as the business expert on quality management.

The position optimizes quality systems and processes and ensures alignment with the worldwide business, applicable local regulations & J&J Enterprise standards, the quality vision and/or Policy, and provides a measurable impact to quality, cost, and customer value. The position supports product launches, identifies opportunities to continuously improve quality, cost, and time factors, consistent with business objectives. Identifies significant (potential) issues, prioritizes for action, and supports improvement opportunities and problem solutions. The position maintains understanding and awareness of current and emerging regulations and the impact to quality and distribution practices.

The position plans, coordinates, and directs quality assurance programs designed to ensure effective and consistent processes with established standards by performing the following duties in partnership with key stakeholders.

 

The scope of this role is applicable to the Commercial Quality operating in MEA cluster (Middle East, Africa)

 

Key responsibilities

• Drive initiatives and improvements in the areas of Purchasing Controls (supplier, distributor, and POLO management), samples management, equipment, and computer systems validation
• Support for management of Quality systems, including CAPA process and systems, document management, change control, training management, preventative maintenance systems, Quality agreements
• Support for management of Quality Management Reviews
• Support for the successful management of internal and corporate audits as well as other logistics and transportation related inspections conducted
• Responsible for the proactive identification and mitigation of compliance risks through metrics reporting, internal audits, and other compliance programs
• Support for timely and accurate metrics and reports per J&J policies. Support departmental goals and objectives, and business measurements
• Responsible for executing and / or supporting Field Actions as per J&J Standards and local Health Authority requirements
• Responsible for keeping oversight of Product Quality Complaints as well as any related activities based on J&J and regulatory standards
• Manages change control records in respective e-system in line with requirements

Requirements

• Bachelor’s or Master’s degree in Bioscience, Engineering or Business or equivalent field
• Relevant business experience in Quality roles, 5 - 7 years working experience in the Medical Device Industry and/or working experience in quality/regulatory function
• Previous experience interfacing with global regulatory agencies, notified bodies, etc. and a history of success and credibility resolving complexity
• Experience with the global demands of the role specifically: healthcare regulatory requirements
• Fluent in English

Core competencies required for this role

• Organized, and able to work effectively with people within a complex social, cultural and political environment
• Must have excellent communication skills, able to inspire trust and quickly build credibility within the Quality & Compliance, Supply Chain, and Commercial organizations
• Must have strong collaboration and influence management skills to partner effectively across functions and operating units
• “Hands-on” operational orientation
• Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results. Recognizes and builds support for change. Engages in constructive conflict
• Ability to fit in well culturally in a complex organization

 

 

Required Skills:

Quality Management Systems (QMS)

 

 

Preferred Skills:

Audit Management, Compliance Management, Issue Escalation, Problem Solving, Quality Standards, Regulatory Environment