Senior Quality Assurance Specialist – Quality Operations

Senior Quality Assurance Specialist – Quality Operations

Requirements

• Bachelor’s degree in a scientific or engineering discipline
• 5-8 years in a GMP environment with at least 3 years of Quality in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC
• Excellent knowledge of the regulations for biologics, cell and gene therapy products
• Strong knowledge of current Good Manufacturing Practices (GMP)
• Comprehensive knowledge of global GMP and regulatory requirements for biotechnology, cell and gene therapy products and Quality by Design approaches
• Strategic mindset, hands-on problem solving skills, and ability to adapt to evolving business needs.

Responsibilities

• Manage the daily quality activities for the quality operations team to ensure facility, process, and materials are in compliance with cGMP requirements
• Partner with other functional team members to ensure harmonization and alignment with Quality Policies, Guidelines, Programs and Systems
• Performs tasks related to all aspects of incoming material and final product disposition for the site
• Responsible for batch record review activities for the site and coordinating Drug Product Release with clients
• Participates in quality shop floor program to ensure compliance of the manufacturing operations
• Responsible for providing quality oversight of the QC laboratory
• Write, review and approve Standard Operating Procedures (SOPs) and associated Work Instructions (WI) and Forms (FRMs), or other documentation, as needed
• Evaluate the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement to organizational agility
• Act as QA lead for the design, implementation, and continuous improvement of QA digital systems (SAP, LIMS, etc.)
• Drive startup activities related to system validations, master data setup and user training
• Coordinate quality systems related activities among impacted individuals, departments, sites and companies as needed to proactively support business processes
• Establish effective partnerships with business units, sites, and individuals to ensure business processes are effectively linked
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
• Cross train on compliance related activities
• Other duties will be assigned, as necessary

Preferred Qualifications

No preferred qualifications provided.