Head of Corporate Quality Technical Development
Czechia
Role Summary
The Head of Corporate Quality will oversee Quality Assurance (QA) across Product Development, Pharmacovigilance, and Regulatory Affairs, ensuring compliance with international standards. The role will drive quality improvements, manage regulatory requirements, and promote a strong culture of quality throughout the organization.
Key Responsibilities
1. Quality Strategy and Leadership
o Define and implement quality strategies aligned with business goals.
o Provide leadership across Quality, Product Development, Pharmacovigilance, and Regulatory Affairs.
o Address quality risks and ensure effective mitigation plans.
2. Compliance and Oversight
o Ensure compliance with GMP, GCP, GDP, and GVP guidelines.
o Maintain quality systems and ensure readiness for audits and inspections.
o Oversee regulatory submissions and manage relationships with global authorities.
3. Product Development and Safety
o Integrate quality control across the product development lifecycle.
o Ensure effective risk management and monitoring of product safety.
o Oversee processes for clinical studies and batch releases.
4. Continuous Improvement
o Drive initiatives to improve quality and operational efficiency.
o Monitor key performance indicators (KPIs) to enhance quality performance.
5. Team Leadership
o Mentor and develop the Quality team, fostering accountability and collaboration.
o Promote a culture of quality and ensure staff are trained on regulatory and quality requirements.
Basic Responsibilities
• Ensure all training and compliance requirements are met.
• Manage budgets according to company guidelines.
• Adhere to internal policies, health and safety rules, and sustainability principles.
Qualifications and Skills
• 10–15 years of experience in Quality Assurance in the pharmaceutical industry, with at least 5 years in a leadership role.
• Bachelor’s or Master’s in Pharmacy, Life Sciences, or related field (advanced degrees preferred).
• Strong knowledge of GMP, GCP, GVP, and global regulatory standards.
• Excellent leadership, communication, and problem-solving skills.