Commercial Quality Lead Tender Business Middle East & Africa

Job Description Summary

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. By creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us, the future is ours to shape!

Through effective leadership and continuous communication with Sandoz d.d. as Legal Entity, MAH/MAH delegate and product supplier, ensure a consistent and compliant tender and stock transfer process in all export markets (including non-governmental organizations NGOs) in Middle East & Africa.

Job Description

Major Activities

• Lead and manage an efficient, compliant Tender and stock transfers process for the Countries in Middle East and Africa operating under the Sandoz dd license in close collaboration and communication with all stakeholders.
• Ensure adequate escalation of issues across the country organization and support their timely resolution & provide quality oversight for GxP incidents and ensure that adequate corrective and preventive actions (CAPA’s) are implemented.
• Continuous communication with relevant GxP stakeholders to maintain the knowledge about Quality relevant regulatory requirements in each country, ensure that processes are in place to communicate country specific requirements to the region and headquarter organization for all GXP areas and assess their implications for the compliance of existing processes and systems. Initiate remediation activities, as necessary, to ensure ongoing compliance.
• Closely monitor that the Sandoz dd QMS quality-relevant processes within the Country Organization are compliant with the Sandoz dd QMS and non-compliance is appropriately addressed via corrective and preventive actions (CAPA).
• Provide Quality oversight and governance of all GxP processes to ensure proactive compliance with all pharmaceutical laws, the Sandoz Quality Manual and Policies, as well as Industry Best Practices.
• Prevent quality or regulatory non-compliance issues which could lead to product stock-out or withdrawal, product approval delays or which would negatively impact the financial performance of the company, as well as the company reputation.
• Act as the single point of contact for export markets hub QA for the Countries in Middle East and Africa operating under the Sandoz dd license, support management of audits / inspections / self-inspections and management of distributors, Quality Plan implementation, Quality Management Review, Quality Risk assessments.
• Management of Risks and issues:
• Exception management (Complaints, Deviations, Quality Events, CAPAs resulting from exceptions), Incident management including recall management, Returns management, Risk assessment of unexpected product issues, Communication of unexpected product issues with Health Authorities. Support the development of a Quality Culture with high awareness on Sandoz values and behaviours.

Key Performance Indicators

• Robust and effective QMS relevant to export markets implemented
• Quality and compliance metrics monitoring system effectively implemented.
• Tender process followed in full compliance with Sandoz processes/procedures
• Customer/stakeholder satisfaction and corresponding feedback tracked regularly
• Performance against Key Quality Indicators
• Awareness of Sandoz business in each export market within responsibility: marketed products, business priorities and key projects

What you’ll bring to the role:

• Bachelor’s Degree in a Scientific field e.g. Pharmacy, Chemistry or other Life Science
• +5 years of experience in Pharmaceutical Industry across Quality: Commercial / Quality Operations/ Manufacturing / Development.
• Fluency in English and local language (oral and written), additional language(s) a plus.
• Expert in understanding of GxP regulations
• Prior experience in the development and implementation of Quality Management Systems. dealing with Health Authorities as well as in management of tenders
• Leadership and people management. Good communication skills.
• Business Exposure, Project Management and execution.
• Job Location: Egypt or Turkey

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! 

Join us!

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

#Sandoz

Skills Desired

Agility, Audit Management, Business Acumen, Business Partnering, Collaboration, Communication Skills, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Goal-Oriented, Guideline, Inspection Preparedness, Leadership, Logical Thinking, Problem Solving Skills, Qa (Quality Assurance), Quality Decision Making, Quality Management, Regulation, Self-Awareness, Stakeholder Management, Teamwork, Technological Expertise

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