Director of Quality

hace 7 días

Madrid, Madrid, España Barrington James A tiempo completo
M

  • JOB TYPE
  • Permanent
  • EMP TYPE
  • Full-Time
  • EXPERTISE
  • Quality Assurance
  • SALARY TYPE
  • Annually
  • SALARY
  • Negotiable
  • Job Description: Director of Quality (Pharmaceutical Vaccine Manufacturing)
  • Location: Madrid, Spain
  • Company Overview:
  • We are a leading pharmaceutical company dedicated to the research, development, and manufacturing of innovative vaccines to address global health challenges. Our commitment to quality and safety is paramount as we strive to provide effective and reliable vaccines to improve public health worldwide. We are currently seeking a highly skilled and experienced Director of Quality to lead our quality assurance efforts in our state-of-the-art vaccine manufacturing facility in Madrid, Spain.
  • Role Overview:
  • As the Director of Quality, you will play a critical role in ensuring the highest standards of quality, compliance, and regulatory adherence throughout the vaccine manufacturing process. Your primary responsibility will be to develop and implement robust quality systems and processes to meet regulatory requirements and support the successful delivery of safe and efficacious vaccines. You will work closely with crossfunctional teams, including R&D, manufacturing, regulatory affairs, and external stakeholders to drive continuous improvement and maintain a culture of quality excellence.
  • Responsibilities:
  • Develop and execute the overall quality strategy, policies, and procedures in alignment with regulatory requirements and industry best practices.
  • Lead a team of quality professionals and provide guidance and mentorship to ensure effective quality oversight across all stages of vaccine manufacturing.
  • Establish and maintain quality systems, including quality control, quality assurance, and quality risk management, to ensure compliance with relevant standards, regulations, and guidelines.
  • Conduct regular audits, inspections, and assessments to identify areas for improvement and implement corrective and preventive actions as necessary.
  • Collaborate with crossfunctional teams to develop and implement robust quality control plans and ensure timely release of vaccine batches for distribution.
  • Drive a culture of quality, continuous improvement, and operational excellence throughout the organization by fostering awareness, training, and accountability.
  • Stay updated on industry trends, regulatory changes, and emerging best practices in pharmaceutical vaccine manufacturing, and this knowledge to enhance quality systems and processes.
  • Foster strong relationships with regulatory agencies, ensuring compliance with regulatory inspections and timely submission of required documentation and reports.
  • Lead investigations of quality incidents, deviations, and nonconformances, and oversee the implementation of effective corrective and preventive actions.
  • Monitor and analyze quality performance metrics and provide regular reports and recommendations to senior management.
  • Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related field. Advanced degree preferred.
  • Extensive experience (10+ years) in quality management roles within the pharmaceutical industry, with a focus on vaccine manufacturing.
  • Indepth knowledge of international regulatory requirements and guidelines, including GMP, GCP, ICH, and relevant regulatory frameworks specific to vaccines.
  • Proven track record of successfully leading quality assurance initiatives, ensuring compliance with regulatory standards and achieving quality objectives.
  • Strong understanding of vaccine manufacturing processes, including upstream and downstream operations, and quality control testing methodologies.
  • Excellent leadership and managerial skills, with the ability to inspire, motivate, and develop a highperforming team.
  • Exceptional problemsolving and decisionmaking abilities, with a keen attention to detail and a commitment to ensuring product safety and quality.
  • Effective communication and interpersonal skills, with the ability to collaborate and influence stakeholders at all levels of the organization.
  • Fluency in English and Spanish, both written and verbal.
  • If you are a dedicated and resultsdriven professional with a passion for ensuring the highest standards of quality in pharmaceutical vaccine manufacturing, we encourage you to. Join our team and contribute to our mission of improving global health through innovative vaccine solutions.
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