Senior Specialist Quality Compliance Expert
3 days ago
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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