Region META Quality Head 100%(m/f/d)

The position may be located either in Turkey or Egypt

The Regional QA Head META is responsible for overseeing and directing all Quality Assurance (QA) activities and initiatives across the META region. This includes the implementation and continuous improvement of the Quality Management System (QMS), ensuring compliance with company standards, local and international regulations (GMP, GDP, GLP), and fostering a culture of quality, data integrity, and operational excellence. The role involves developing and leading regional and local QA teams, ensuring effective training, documentation, and archiving practices, and acting as the primary interface with regulatory authorities and external partners. The Regional QA Head META also leads escalation processes, supports audits and inspections, and drives initiatives to enhance quality performance and compliance across the region.

Key Responsibilities 

1. Release and Distribution:

• Lead batch release and certification for products where Arcera is the Marketing Authorization Holder (MAH), exercising independent decision-making authority for batch release or rejection

2. Quality Management System (QMS) Implementation:

• Oversee the implementation, maintenance, and continuous improvement of the QMS, including Technical Quality Agreements (TQAs) and all quality-related documentation, ensuring compliance with company, local, and international regulations.

3. Compliance and Regulatory Affairs:

• Ensure all products and processes comply with market authorization, GMP, GDP, and GLP requirements. Act as the primary interface with regulatory authorities for GxP-related activities, including pharmacovigilance and regulatory submissions.

4. Quality Culture and Data Integrity:

• Establish and promote a culture of quality and data integrity across the META region, acting as a data integrity ambassador and driving DI best practices.

5. Escalation and Issue Management:

• Lead the escalation process for quality-related matters in the META region, track investigations, and consolidate findings to ensure timely and effective resolution.

6. Audit and Inspection Support:

• Support and coordinate internal and external audits and inspections, ensuring readiness and effective follow-up on findings.

7. Performance Monitoring and Reporting:

• Monitor the effectiveness of quality systems, including self-inspections, KPI tracking, and participation in management reviews. Track and report on site quality KPIs and manage hot topic issues.

8. People Leadership and Talent Management:

• Develop and lead regional and local QA teams, fostering talent management and organizational development. Conduct regular performance reviews of direct reports against agreed goals and KPIs.

9. Cross-Functional Collaboration:

• Work collaboratively with cross-functional teams to ensure alignment with global quality KPIs, annual quality plans, and business objectives.

10. Continuous Improvement:

• Drive initiatives to enhance quality performance, process efficiency, and compliance, fostering a culture of continuous improvement throughout the region
  

Key Competencies 

• Quality Assurance Expertise: Deep understanding of QA, pharmaceutical manufacturing, and quality control.
• Auditing & Compliance: Experience in auditing and ensuring compliance with international GMP, GDP, and GLP requirements with focus on Out of Specification, Transport Validations etc...
• Leadership & People Development: Proven ability to lead, coach, and develop teams across diverse cultures.
• Analytical Thinking: Ability to analyze training data, audit findings, and quality metrics to drive improvements.
• Collaboration: Works effectively across functions and with diverse teams.
• Change Management: Supports and drives change initiatives in the META region.
• Regulatory Knowledge: Expertise in regulatory requirements for target markets.
• Communication: Strong communication and interpersonal skills.
• Problem Solving: Able to solve complex situations and problems.
• Cultural Awareness: Understanding and adapting to different cultural behaviors.
• Result- and Process-Oriented: Focused on achieving results and optimizing processes.
• Service/Customer Orientation: Committed to internal and external customer satisfaction.

Qualifications & Experience 

• Degree in Life Sciences, Pharmacy, Chemistry, or related field; advanced degree preferred.
• 5+ years’ experience in pharmaceutical quality management systems, with a focus on QA leadership, training, documentation, or data integrity.
• Experience in developing and delivering training programs.
• Strong knowledge of GMP, GDP, GLP, and QC requirements.
• Experience with electronic documentation and learning management systems.
• Audit support and regulatory inspection experience.
• Excellent organizational and communication skills.
• Proven ability to drive process improvements and foster a culture of quality and compliance.
• Business fluent English; additional languages are an asset

In connection with your application, Arcera will collect, process and store personal data about you. Our Privacy Notice for Prospective Employees, also available in German, provides an overview of the personal data that Arcera processes during the application process.

Note: This Privacy Notice may be updated by Arcera, we therefore invite you to consult the latest versions via the above links. In the event of any conflict between the English and German versions of this Privacy Notice, the English version shall prevail.