Job Title: Head of Quality Assurance - Pharmaceutical Industry

Job Summary:

The Head of Quality Assurance in the pharmaceutical industry is a leadership role responsible for ensuring that all products meet regulatory requirements, industry standards, and internal quality standards. This position plays a crucial role in maintaining and improving the quality management system within the organization. The individual in this role will lead a team of quality professionals, develop and implement quality assurance strategies, and collaborate with cross-functional teams to drive continuous improvement in product quality and compliance.

Key Responsibilities:

1. Leadership and Team Management:
   • Provide strategic leadership to the Quality Assurance (QA) team, ensuring a high level of engagement, motivation, and professional development.
   • Build and maintain a high-performance culture within the QA department.
   • Foster collaboration and effective communication within the QA team and with other departments.
2. Quality Management System (QMS) Development:
   • Establish, implement, and maintain the QMS in accordance with regulatory requirements and industry best practices.
   • Ensure that the QMS is continuously improved and aligned with organizational goals.
3. Regulatory Compliance:
   • Stay current with applicable regulatory requirements and industry standards, and ensure the organization's compliance.
   • Interact with regulatory authorities and participate in regulatory inspections.
4. Quality Audits and Inspections:
   • Plan and execute internal and external quality audits to assess compliance with regulatory requirements and company standards.
   • Prepare and lead the organization through regulatory inspections.
5. Risk Management:
   • Implement and oversee a risk management program to identify and mitigate quality risks across the organization.
6. Document Control and Training:
   • Establish and maintain document control processes to ensure the accuracy and accessibility of quality documentation.
   • Develop and oversee training programs to ensure that personnel are adequately trained on quality processes and procedures.
7. Supplier and Vendor Management:
   • Establish and maintain processes for evaluating and monitoring suppliers and vendors to ensure the quality of incoming materials and services.
8. Continuous Improvement:
   • Drive a culture of continuous improvement, utilizing quality metrics and key performance indicators to identify and implement opportunities for enhancing product quality and operational efficiency.

Qualifications and Experience:

• Bachelor's or advanced degree in a relevant scientific or engineering discipline.
• Extensive experience in quality assurance within the pharmaceutical industry, including leadership roles.
• In-depth knowledge of regulatory requirements, such as FDA, EMA, and other relevant authorities.
• Strong understanding of GMP (Good Manufacturing Practice) principles.
• Excellent leadership, communication, and interpersonal skills.
• Experience in managing and leading teams.
• Familiarity with quality management tools and methodologies.

Additional information: Candidates who meet the above conditions can send their CVs to email:  [најави се за да го видиш е-маилот]