Description
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of Our Credo. It’s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.
We are looking for a Commercial Quality Supervisor in Riyadh, Saudi Arabia.
The position is accountable for the oversight and execution of Quality Management Systems and Compliance at all Deliver locations within the corresponding geographical area of Saudi Arabia that receive, pick, pack, store, inspect, repack/relabel and deliver finished goods to Customers, Retailers, Wholesalers, and Distributors.
Role responsibilities
Responsible for the qualification and approval of GXP suppliers.
Responsible for the development and maintenance of quality agreements for the outsourced activities.
Responsible for the monitoring activities of the suppliers performance.
Distribution and Inventory Management Processes.
Responsible for execution and overseeing the controls and quality standards for all distribution and inventory management activities (e.g., receiving, pick, pack, lot reconciliation).
Responsible for robust product impact evaluation and execution of product disposition according product owner instructions.
Responsible for evaluating the company’s quality and distribution process capabilities against company and industry standards and regulatory expectations.
Special Processes (Repack-Relabel, Temperature Control & Monitoring) Responsible for defining, designing, and implementing requirements for repackaging and relabeling operations (‘not for sale’ sticker).
Responsible for ensuring the appropriate handling of distribution related customer complaints (Delivery Service Issues) including track and trend and mitigation of Quality related issues.
Responsible for ensuring that a change control system is implemented ensuring that any GXP changes are appropriately controlled.
Responsible for management of Quality systems, including NCs/CAPA process and systems, document management, change control, training management, Quality agreements for the activities that are under the scope of the position.
Act as Quality representative on the Management Reviews.
Provide support to the successful management of all Health Authority inspections as well as other logistics and transportation related inspections.
Responsible for the proactive identification and mitigation of compliance risk through QScan, internal audits, and other compliance programs.
Accountable and responsible for timely and accurate metrics and reports per J&J policies.
Responsible and accountable for the management of facility licenses.
Support departmental goals and objectives, and business measurements for department.
As GDP Responsible person for the distribution in the Saudi market.
Implementation and efficiency assurance of Quality Management System (QMS) in scope of GDP processes
Monitoring the QMS effectiveness.
Approval, updating and control over compliance with SOP/WI requirements
Monitoring of the trainings progress and assessment of the trainings effectiveness in order to find areas for improvement.
Instructing staff on SOP/WI requirements, where it is required. Ensures the maintenance of quality records on product testing, nonconformance, project outcomes, and that stakeholder input is filed in an accurate and timely manner.
Compiles, reviews, and audits change control documentation and tracks the approval process.
Contributes to the development of corrective action plans and monitors implementation. Reports on closure of corrective and preventive actions.
Monitors and leads investigations, recognizes trends and presents reports for assigned quality processes.
Reviews reports on current quality systems and supports improvements in order to enhance quality and reduce cycle time.
Assures preparation and continuous readiness for audits and inspections.
Monitors trends, identifies issues, recommends, and implements appropriate actions. Develops, implements, and reviews standard operating procedures for interactions with contract manufacturers.
Qualifications
Education: (minimum required for competent performance in this position)
University/Bachelors Degree or Equivalent in Life Science/Engineering.
Masters and/or Certifications in Quality Assurance, Project Management, and innovation.
Skill Sets and Competencies:
Advanced analytical skills and ability to translate data and customer learning into actionable recommendations.
Interdependent partnering skills with multi-task capacity.
Advanced communication and presentation skills
Process methodology orientation & practice
Strong IT skills including Microsoft Office package
Years of experience: (minimum required to be able to handle the position)
7 years of experience in Pharma, Medical Devices and Consumer Health quality and Middle East/Africa Health Authorities Regulations.
Process oriented Individuals are required.
Travel: Local, 25%
Compliance Statement:
Observes and promotes all regulatory requirements as defined per applicable regulations, rules and procedures established by the Company, and notifies any violation or deviation to the immediate supervisor or appropriate authority.
Complies with own training requirements to perform duties of own job.
Required Business & Leadership Or Technical Experiences – Leadership behaviors required
Strategic Thinking
Outward looking-Customer centric
Business and results driven
Interdependent partnering ability
Prudent risk taking
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Primary Location Europe/Middle East/Africa-Saudi Arabia-Ar Riyad-Riyadh
Organization Johnson & Johnson Medical Saudi Arabia Ltd Legal Entity for [Medical devices]
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