Job Description

Position Summary

We are seeking a Senior Specialist, R&D Quality Assurance to support our clinical development programs by ensuring adherence to global GCP standards and regulatory requirements. In this role, you will act as a key Quality Assurance (QA) representative across assigned clinical studies, partnering closely with cross-functional R&D teams. You will also engage with external collaboratorsincluding CROs, laboratories, and other clinical vendorsto foster a culture of quality and compliance throughout all stages of clinical trial execution. This position requires strong subject matter expertise in GCP and the ability to proactively support high-quality, inspection-ready clinical operations.

Key Responsibilities

• Serve as the QA representative on clinical study teams, providing GCP guidance and support.
• Collaborate with external partners (e.g., CROs, labs, vendors) to ensure compliance with applicable global regulations, standards, and internal procedures.
• Act as a quality subject matter expert (SME) for assigned programs and initiatives.
• Support and prepare for Regulatory Authority GCP inspections.
• Contribute to the development and improvement of QA systems, processes, and tools.
• Manage internal QA activities and contribute to the oversight of contract QA personnel and third-party auditors.

Qualifications

Education & Training:

• Bachelors degree (BA/BS) in Life Sciences or a related discipline required.

Experience & Skills:

• Minimum of 5 years of hands-on GCP Quality Assurance experience within a regulated environment (pharmaceutical, biotechnology, CRO, or medical device industry).
• In-depth knowledge of FDA, ICH, and other relevant GCP regulations and guidelines.
• Direct experience supporting Regulatory Authority GCP inspections.
• Experience managing both internal teams and external vendors/auditors.
• Strong communication and interpersonal skills, with the ability to navigate cross-functional interactions in a collaborative, solutions-oriented manner.
• Demonstrated ability to thrive in a dynamic, fast-paced setting with shifting priorities.

Mostly remote, must come onsite when/as needed.

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