Senior Specialist Quality Compliance Expert

3 days ago


Holly Springs, United States BioSpace, Inc. Full time
Job Details

Defy Imagination with a Career in Quality Compliance

We are seeking a highly skilled Senior Specialist Quality Compliance to join our team at BioSpace, Inc. As a key member of our Regulatory Compliance function, you will play a critical role in ensuring the quality and compliance of our products and processes.

Key Responsibilities:
  • Collaborate with cross-functional teams to prepare for and execute inspections, ensuring a perpetual state of inspection readiness.
  • Lead the generation of formal response commitments and cascade inspection outcome information across the organization.
  • Identify improvement opportunities and track commitment and improvement actions to completion.
  • Establish and maintain best practice and effective inspection lifecycle processes.
  • Apply knowledge of current regulations, standards, and guidelines to support inspections.

Requirements:
  • High school diploma or equivalent and 12 years of quality compliance experience, or equivalent combination of education and experience.
  • Bachelor's degree in Life Sciences or Engineering, or equivalent experience.
  • 7+ years of related work experience in the pharmaceutical industry, with progressively increasing responsibility and proven experience in compliance, data analysis, project management, and quality systems.
  • Experience managing staff and/or leading cross-functional teams, projects, and/or programs.
  • Thorough understanding of quality management systems and quality control processes related to bulk drug and drug product for clinical and commercial operations.

What We Offer:
  • Competitive base salary and comprehensive Total Rewards Plans.
  • Opportunities for professional growth and development.
  • A collaborative and dynamic work environment.

Apply Now:

Join us in our quest to serve patients above all else. Apply now for a career that defies imagination.


careers.amgen.com



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