Overview
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. This role partners closely with Manufacturing, Quality Control, and cross-functional teams to ensure compliance with FDA, EU, and ICH regulatory requirements while supporting product disposition, batch record review, investigations, CAPAs, change controls, audits, and continuous improvement initiatives.
The ideal candidate brings strong GMP Quality experience within biologics, cell therapy, or gene therapy manufacturing and possesses the ability to apply regulatory requirements to complex operational situations while promoting a culture of quality throughout the organization.
Duties
Provide end-to-end Quality support for the manufacture of mid-phase through Commercial gene therapies, oncolytics, vaccines, immunotherapies, or other biological products under the regulatory purview of current Good Manufacturing Practices (21 CFR Parts 210/211, 600, and 610); to include, but not limited to, the following:
o Review and approve master batch records, material specifications, quality control test methods/validations, raw material inspection and release packets, environmental monitoring data, and any other documentation associated with the development, execution, and review/approval of manufactures for product release.
o QA on the Floor
o Room Release activities
o Drafts and/or approves Certificates of Analysis, Certificate of Compliance, and any other certificates issued to Clients in support of product disposition and release.
o Acts as QA representative in Client meetings; providing sound Quality perspectives, citing the appropriate regulations, standards, or guidance to resolve potential issues.
o Acceptance Quality Limit (AQL) inspections
o Review and approve master batch records, material specifications, quality control test methods/validations, raw material inspection and release packets, environmental monitoring data, and any other documentation associated with the development, execution, and review/approval of manufactures for product release.
o QA on the Floor
o Room Release activities
o Drafts and/or approves Certificates of Analysis, Certificate of Compliance, and any other certificates issued to Clients in support of product disposition and release.
o Acts as QA representative in Client meetings; providing sound Quality perspectives, citing the appropriate regulations, standards, or guidance to resolve potential issues.
o Acceptance Quality Limit (AQL) inspections
- Write, review, and revise Standard Operating Procedures (SOPs)
- Provide QA oversight to ensure adherence to procedures, while also increasing compliance awareness and promoting a culture of quality throughout the company through strong collaborations with the cross-functional teams.
- Readily identify gaps in compliance during conversations and can devise an equitable solution that resolves the issue(s) and ensures regulatory compliance.
- Provide training in GxP regulations, best practices, and internal requirements
- Provide direct support in investigating complex issues and non-conformances – is able to use critical thinking to establish investigation plans and effective, data-driven discussions in evidence of root causes.
- Be proactive in forecasting upcoming tasks and is highly communicative with Management and other departments in establishing business priorities.
- Establish and implement effective CAPA and Change Control plans
- Performs internal and external (i.e. supplier/sub-contractor) audits.
- Assist with the analysis of trends and metrics to recommend and implement continuous quality improvements.
- Interface with contract testing organizations and alliance partners to resolve quality-related issues with minimal supervision
- Host Client audits and/or regulatory inspections.
- Other duties as assigned.
Qualifications & Education Requirements
- Minimum of BS in Life Science or equivalent years of education and/or years of experience (i.e. Associate’s Degree and minimum 5 years in a regulated pharmaceutical environment)
- A minimum of 5-7 years’ experience in a technical or administrative field related to the industry or equivalent in a GMP (biologics) environment is required.
- 5+ years of experience in biologics, cell therapy or gene therapy manufacturing Quality.
Preferred Qualifications
- Strong foundational knowledge of US FDA cGMP regulations is required, and some experience with EU GMPs (Directives 2001/83/EC and 2003/94/EC) and ICH guidelines is highly preferred. Must possess the capacity for applying regulatory knowledge to practical situations throughout the organization.
- Understands the distinct difference to achieve and sustain manufacture of Commercial Products in the regulatory space, not just early phase clinical materials.
- Experience with GMP manufacture of biological products; technical aptitude needed for reviewing master batch records for production or testing and can readily identify process gaps.
- Critical thinking and resourcefulness to help solve complex issues that involve various cross-functional teams.
- Strong communication skills, both with internal and external parties. Awareness of when to escalate matters to Management.
- Can handle difficult conversations with professionalism and objectivity.
- Shows initiative in seeking out work and not waiting for instruction. Understanding the objectives of the Quality team are shared, and success is dependent on partnerships and the willing support of the entire unit.
- Ability to work independently and possesses the knowledge and credentials to represent the Quality unit objectives without constant Management oversight.
- Capable of making decisions or can provide input to Management for reaching resolutions.
- Possesses a willingness to share knowledge, even mentoring more junior members, where possible.
- Highly meticulous and detail-oriented in reviews; is able to sort through many data sets to assemble a full picture with the understanding of its outputs and impact.
Physical Requirements
Physical demands: (check one)
- sedentary (< 10 lbs.) x light work (< 20 lbs.)
Physical activity:
- walking
- typing/grasping
- standing
- hearing
- Visual acuity (preparing/analyzing data, transcribing, reading, use of measuring devices, machinery labels, color differentiation, etc.)
- Personnel may be required to be vaccinated in order to perform some job duties.
- Working conditions (indoor/outdoor, noise levels, hazards, working quarters)
Travel Requirements
Supervisory Responsibilities
- This position does not require previous supervisory experience.
Location
This position is onsite in Alachua, FL (Gainesville, FL metropolitan area)
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Retirement plan
- Vision insurance
Application Question(s):
- Will you now or in the future require employer sponsorship for employment visa status?
- Do you have at least 5 years of experience in a GMP-regulated biologics, cell therapy, gene therapy, or pharmaceutical environment?
- Do you have experience reviewing or approving GMP quality documentation such as batch records, deviations, CAPAs, change controls, specifications, or product release documentation?
- Do you have experience hosting or supporting FDA, client, or regulatory inspections?
- Do you have experience working in a gene therapy, cell therapy, biologics, vaccine, or CDMO environment?
Education:
Experience:
- GMP biologics, cell therapy, or gene therapy quality: 5 years (Required)
Work Location: Hybrid remote in Alachua, FL 32615
