Senior Quality Operations Specialist

Ascend Advanced Therapies FL, Inc. • Alachua, FL

1d • Onsite

About The Position

Ascend Advanced Therapies is seeking a Senior Quality Specialist, Quality Operations to provide end-to-end Quality Assurance support for the manufacture and release of gene therapies, oncolytics, vaccines, immunotherapies, and other biological products in a GMP-regulated environment. The role partners with Manufacturing, Quality Control, and cross-functional teams to ensure compliance with FDA, EU, and ICH regulatory requirements and to support product disposition, batch record review, investigations, CAPAs, change controls, audits, and continuous improvement initiatives.

The position provides Quality support for mid-phase through commercial manufacturing and release of biological products. The specialist applies regulatory requirements to operational situations and promotes a culture of quality. The role is onsite in Alachua, Florida, and requires less than 10% travel. No previous supervisory experience is required.

Requirements

• Minimum of a bachelor's degree in Life Science or equivalent education and/or experience; an associate degree with at least five years in a regulated pharmaceutical environment is given as an example of equivalent qualifications.
• At least 5–7 years of experience in a technical or administrative industry-related field, or equivalent experience in a GMP biologics environment.
• At least five years of Quality experience in biologics, cell therapy, or gene therapy manufacturing.
• Strong foundational knowledge of US FDA cGMP regulations.
• Ability to apply regulatory knowledge to practical situations throughout the organization.
• Critical thinking and resourcefulness in solving complex issues involving cross-functional teams.
• Strong communication skills with internal and external parties, including awareness of when to escalate matters to Management.
• Ability to handle difficult conversations professionally and objectively.
• Initiative and ability to work independently and represent Quality unit objectives without constant Management oversight.
• Ability to make decisions or provide input to Management toward resolutions.
• Meticulous, detail-oriented review skills and ability to evaluate multiple data sets and understand their outputs and impact.

Nice To Haves

• Experience with EU GMPs, including Directives 2001/83/EC and 2003/94/EC, and ICH guidelines.
• Understanding of the regulatory requirements for achieving and sustaining commercial product manufacture, beyond early-phase clinical materials.
• Experience with GMP manufacture of biological products and technical aptitude for reviewing production or testing master batch records and identifying process gaps.
• Willingness to share knowledge and mentor more junior team members.

Responsibilities

• Provide end-to-end Quality Assurance support for the manufacture and release of biological products in a GMP environment.
• Review and approve master batch records, material specifications, quality control test methods and validations, raw material inspection and release packets, environmental monitoring data, and other manufacturing and product-release documentation.
• Provide QA support on the floor and perform room-release activities.
• Draft and/or approve Certificates of Analysis, Certificates of Compliance, and other client certificates supporting product disposition and release.
• Represent QA in client meetings and provide Quality perspectives based on applicable regulations, standards, and guidance.
• Perform Acceptance Quality Limit (AQL) inspections.
• Write, review, and revise Standard Operating Procedures (SOPs).
• Provide QA oversight of procedural adherence and promote compliance awareness and a culture of quality through cross-functional collaboration.
• Identify compliance gaps and develop solutions that address issues and ensure regulatory compliance.
• Provide training in GxP regulations, best practices, and internal requirements.
• Support investigations of complex issues and non-conformances, develop investigation plans, and use evidence and data-driven discussion to establish root causes.
• Forecast upcoming tasks and communicate with Management and other departments to establish business priorities.
• Establish and implement effective CAPA and Change Control plans.
• Perform internal and external audits, including supplier and subcontractor audits.
• Analyze trends and metrics and recommend and implement continuous quality improvements.
• Work with contract testing organizations and alliance partners to resolve quality-related issues with minimal supervision.
• Host client audits and/or regulatory inspections.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior