Quality Assurance Manager

vor 1 Monat

Baar, Zug, Schweiz Biogen Vollzeit
About the Role

Job Summary

We are seeking a highly skilled and experienced Quality Assurance Manager to join our team at Biogen. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.

Key Responsibilities
  • Quality Assurance and Compliance
    • Develop and implement quality assurance policies and procedures to ensure compliance with regulatory requirements.
    • Conduct regular audits and inspections to ensure adherence to quality standards.
    • Investigate and resolve quality-related issues and deviations.
  • Regulatory Affairs
    • Ensure compliance with regulatory requirements, including GMP, GDP, and other relevant regulations.
    • Develop and maintain relationships with regulatory authorities and industry partners.
    • Stay up-to-date with changes in regulatory requirements and ensure that our quality systems are aligned with these changes.
  • Quality System Management
    • Develop and implement quality system procedures to ensure compliance with regulatory requirements.
    • Conduct regular reviews and updates of quality system procedures to ensure they remain effective and compliant.
    • Ensure that all quality system procedures are properly documented and communicated to relevant stakeholders.
  • Training and Development
    • Develop and deliver training programs to ensure that all employees understand their quality-related responsibilities.
    • Conduct regular training sessions to ensure that employees are aware of changes in regulatory requirements and quality system procedures.
  • Communication and Collaboration
    • Communicate quality-related issues and concerns to relevant stakeholders, including management, employees, and regulatory authorities.
    • Collaborate with other departments, including manufacturing, supply chain, and regulatory affairs, to ensure that quality-related issues are properly addressed.
Requirements
  • Education
    • Master's degree in a relevant field, such as pharmaceutical science, quality assurance, or a related field.
  • Experience
    • At least 5 years of experience in quality assurance, regulatory affairs, or a related field.
    • Proven experience in developing and implementing quality assurance policies and procedures.
    • Experience in conducting audits and inspections, and resolving quality-related issues and deviations.
  • Skills
    • Strong knowledge of GMP, GDP, and other relevant regulations.
    • Excellent communication and interpersonal skills.
    • Ability to work independently and as part of a team.
    • Strong analytical and problem-solving skills.
What We Offer

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced quality assurance professional looking for a new challenge, please submit your application.

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