ESO Quality Manager – 8735

2024-05-02
Application deadline closed.

Job Description

We are looking for a Senior ESO Quality Manager to join our dynamic team

What You Will Work On:

  • Select, monitor, guide, and promote quality at ESO/API suppliers to ensure products meet quality standards and regulatory compliance.
  • Support markets and distributors with products provided by ESOs, ensuring compliance with applicable regulations.
  • Provide support to manufacturing sites and ESOs to maintain product quality and regulatory compliance.
  • Support product development quality through clinical supplies, development reports, and documentation reviews as appropriate.
  • Initiate continuous improvement actions and develop business excellence approaches across ESO/API suppliers.
  • Ensure compliance with GMP/GDP/ISO activities in the scope of medicinal products, adhering to the following requirements:
    • EU GMP Guideline Chapter 4/US 21CFR 4, 210, and 211
    • Swiss MLPO Chapter 2, Sections 1-3
    • EU GDP Guideline according to 2013/C 343/01
    • ISO 13485 / EU MDR / US 21CFR 820
  • Oversee and ensure the team works in compliance with these regulations and guidelines.

What You Bring:

  • Experience in quality assurance, quality control, or regulatory compliance within the pharmaceutical or biotechnology industry.
  • Deep understanding of regulatory requirements, including EU GMP Guideline, US 21CFR, Swiss MLPO, EU GDP Guideline, ISO 13485, EU MDR, and US 21CFR 820.
  • Knowledge of quality management systems, such as ISO 9001 and ISO 13485, and their application to product development and manufacturing.
  • Experience working with external suppliers (ESOs) and ensuring their compliance with quality standards.
  • Strong analytical and problem-solving skills, with an ability to identify and address quality issues efficiently.
  • Excellent communication and interpersonal skills to work effectively with internal and external teams.
  • Strong attention to detail and ability to manage multiple priorities in a fast-paced environment.
  • Familiarity with continuous improvement methodologies and business excellence practices.

If this sounds interesting, please send your CV to cv@veritaz.se