Product Disposition Senior Specialist, Quality

Overview

• Support the compliant disposition of Gene Therapy products across manufacturing stages.
• Review batch documentation and coordinate with internal and external stakeholders.
• Execute quality system transactions in Oracle for product release.
• Collaborate cross-functionally to ensure timely and effective product disposition.
• Maintain and develop Product Specification Files (PSF).
• Escalate quality issues and risks to management promptly.
• Work in a fast-paced, regulated environment with a quality-first mindset.
• Provide support for QA systems and related business processes.

Key Responsibilities & Duties

• Conduct detailed reviews of batch documentation for investigational and commercial products.
• Support disposition processes for various product types including cell banks and finished goods.
• Coordinate QP batch certification activities and respond to queries.
• Execute Quality Management System transactions to facilitate product release.
• Collaborate with teams such as Quality Control, Supply Chain, and Regulatory Affairs.
• Escalate quality-related issues and risks to management effectively.
• Assist in maintaining compliance with cGMP regulations and quality systems.
• Support the implementation and maintenance of Veeva eQMS systems.

Job Requirements

• Bachelor’s Degree in science, engineering, or related discipline required.
• Minimum of 5 years’ experience in GxP-regulated pharmaceutical or biotechnology environment.
• Experience in product disposition, batch record review, or QA operations preferred.
• Familiarity with cGMP regulations and quality systems (US/EU).
• Proficiency with Oracle or similar ERP systems is highly desirable.
• Strong organizational, communication, and problem-solving skills.
• Ability to manage multiple priorities independently in a fast-paced environment.
• Experience with Veeva eQMS systems is a plus.