QA Clinical Supply Chain

Sr. Associate QA Clinical Supply Chain | Amgen Breda

Are you a Quality Assurance professional with experience in GMP-regulated environments and a passion for ensuring the quality and compliance of clinical products? We are currently supporting Amgen Breda in the search for a Sr. Associate QA Clinical Supply Chain to join their Clinical Quality team.

About the Role

As a Sr. Associate QA Clinical Supply Chain, you will be responsible for providing Quality Assurance oversight throughout the clinical supply chain and supporting clinical production activities. You will ensure that Investigational Medicinal Products (IMPs) are handled, packaged, distributed, and reviewed in compliance with GMP, GDP, and applicable regulatory requirements.

Working closely with stakeholders across Supply Chain, Warehouse Operations, Clinical Packaging, Regulatory Affairs, and Manufacturing, you will play a key role in maintaining product quality and supporting clinical trials worldwide.

Key Responsibilities

• Perform batch record reviews to support Qualified Person (QP) certification of Investigational Medicinal Products (IMPs).
• Review and approve clinical label artwork.
• Assess temperature excursions during transportation and storage of clinical products.
• Support the investigation and resolution of quality and compliance issues related to manufacturing and distribution activities.
• Review and approve minor deviations while ensuring compliance with established procedures.
• Author, maintain, and improve SOPs and work instructions.
• Review procedures to ensure alignment with corporate, site, and regulatory requirements.
• Prepare and report monthly quality metrics.
• Collaborate cross-functionally to identify and resolve quality-related issues.
• Provide on-the-floor QA support for Clinical Packaging and Labeling Operations.
• Conduct pack checks, batch record reviews, and QA compliance checks during manufacturing activities.

Requirements

• Master's degree in Life Sciences, Biotechnology, Pharmacy, or a related scientific discipline.
• Minimum of 3 years of experience within Quality Assurance or Manufacturing in the pharmaceutical or medical device industry.
• Experience with batch record review, deviations, investigations, and GMP-regulated processes.
• Strong working knowledge of GMP and GDP regulations; GCP knowledge is highly desirable.
• Excellent written and verbal communication skills in English.
• Strong analytical and problem-solving skills.
• Detail-oriented with a quality-focused mindset.
• Ability to work effectively within cross-functional and international teams.

Preferred Background

Candidates with experience in one or more of the following areas are particularly encouraged to apply:

• Clinical Supply Chain
• Investigational Medicinal Products (IMP)
• Clinical Packaging & Labeling
• Batch Record Review
• Quality Systems
• Deviations, CAPAs, and Investigations
• GMP/GDP Compliance
• Pharmaceutical Manufacturing
• Clinical Operations Support

What's in It for You?

• Opportunity to join a global biotechnology leader.
• Work in an international and highly collaborative environment.
• Contribute directly to the delivery of clinical products supporting patient-focused research.
• Gain exposure to a broad range of quality and supply chain activities.
• Excellent career development and growth opportunities.