Cell & Gene/ATMP Senior Consultant - Qualified Person
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About ProPharma
For the past 20 years, ProPharma has improved patient health and wellness by providing expert advice and solutions that help biotech, med device, and pharmaceutical organizations advance scientific breakthroughs and develop new therapies. We partner with clients across the entire product lifecycle, offering fully customizable consulting services in regulatory sciences, clinical research, quality & compliance, pharmacovigilance, medical information, and R&D technology, aiming to de-risk and accelerate high-profile drug and device programs.
The Role
We are seeking a Cell & Gene/ATMP Senior Consultant – Qualified Person to support clients in the Cell & Gene therapy (ATMP) sector. This is a permanent position based remotely within the EU, with travel to client sites as needed. The role involves leading scientifically rewarding projects within the EU, acting as a key expert in quality and compliance for Cell & Gene Therapy medicinal products.
Key Responsibilities
* Serve as a Subject Matter Expert in quality and compliance for Cell & Gene Therapy products, both investigational and commercial.
* Provide independent consultation and project leadership on challenging projects within the Q&C space.
* Operate under the PPG MIA license as a Qualified Person, handling tasks like batch certification, GxP audits, and QMS development.
* Ensure project success and profitability.
* Stay current with regulatory and technological developments in the field.
* Contribute to the implementation of risk-based and phase-appropriate GxP projects.
* Act as SME in clinical and commercial processes, assessing scope and effort to meet client needs.
* Promote CQA services industry-wide and support continual improvement in customer satisfaction.
* Provide training on Cell & Gene/ATMP Q&C topics to clients and internal teams.
* Support clients and internal units in GxP issues, deviations, and non-conformances, including CAPA implementation.
* Engage with employees at all levels to educate on compliance and drive quality improvements.
Candidate Requirements
* Minimum 10 years of experience in ATMPs/Cell & Gene Therapy.
* Knowledge of manufacturing techniques for cell and gene therapies (e.g., CAR-T, iPSCs, TILs, MSCs) in GMP environments.
* Experience with ATMP manufacturing facility qualifications and validation processes.
* Familiarity with risk assessment tools (FMEA, FTA, HACCP, Gap Analysis).
* Participation in at least one regulatory inspection.
* Availability to be on-site for critical project phases; remote work otherwise.
* Fluent in English.
* Authorized as a QP for ATMPs in Europe (per Directive 2001/83/EC).
* Knowledge of GMO manufacturing site authorization procedures in Europe is a plus.
* Experience with non-cell-based gene therapy products (e.g., viral vectors) is preferred.
ProPharma values diversity and inclusion, fostering a workplace where everyone can be their authentic selves. We are committed to equal opportunity employment and creating a safe, empowering environment for all employees.
***ProPharma Group does not accept unsolicited resumes from recruiters or third parties. Please do not contact us regarding this posting.***
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