Quality Assurance Director

vor 4 Wochen

Frankfurt am Main, Hessen, Deutschland SciPro Vollzeit
Job Title: Head of Quality Assurance

SciPro is seeking a highly skilled and experienced Head of Quality Assurance to lead our Quality Assurance department. The successful candidate will be responsible for ensuring that all pharmaceutical products meet the required quality standards and comply with Good Manufacturing Practices (GMP), EU regulations, and other applicable standards.

Key Responsibilities:
  • Oversee and maintain the Quality Management System (QMS) to ensure compliance with GMP and industry regulations.
  • Conduct and lead internal and external audits, ensuring timely corrective and preventive actions (CAPAs).
  • Review and approve batch records, product releases, and deviations in line with regulatory requirements.
  • Collaborate with cross-functional teams (e.g., R&D, manufacturing) to develop and implement quality processes and systems.
  • Lead investigations into quality issues, identify root causes, and implement long-term solutions.
  • Prepare the company for regulatory inspections and serve as a point of contact for authorities such as the FDA, EMA, and local regulatory bodies.
  • Train and mentor staff on quality procedures, ensuring ongoing compliance and improvement.
  • Drive continuous improvement initiatives using Lean Six Sigma methodologies to enhance operational efficiency.
  • Ensure that all documentation, including SOPs and quality policies, are kept up-to-date and reflect current regulations.
Requirements:
  • Bachelor's degree in Pharmaceutical Science, Chemistry, Biotechnology, or a related field.
  • At least 5 years of experience in quality assurance in the pharmaceutical industry.
  • Strong knowledge of GMP, ISO 9001, and relevant EU and international pharmaceutical regulations.
  • Proven experience managing audits and regulatory inspections.
  • Strong leadership, problem-solving, and communication skills.
  • Proficiency in German and English (both written and spoken).
  • Experience with quality management software (e.g., LIMS, TrackWise) is a plus.

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