Cell&Gene/ATMP Senior Consultant – Qualified Person - Remote based anywhere in the EU
REMOTEPosted 30+ days ago
Job summary
Job post source
This job is directly from ProPharma
Job overview
The Cell&Gene/ATMP Senior Consultant – Qualified Person role at ProPharma involves providing expert consulting in quality and compliance for Cell & Gene Therapy products, impacting client projects across the EU.
Responsibilities and impact
The consultant will act as a subject matter expert in quality and compliance, provide independent consultation, perform Qualified Person tasks like batch certification, support project execution and profitability, keep up with regulatory changes, promote services, train clients and associates, and support quality assurance and compliance activities.
Experience and skills
Requires at least 10 years experience in ATMPs/Cell & Gene Therapy, knowledge of manufacturing techniques in GMP environments, familiarity with facility qualifications, risk assessment tools, regulatory inspection experience, QP authorization for Europe, and fluency in English; preferred experience includes GMO site authorization and non-cell-based gene therapy production.
Work environment and culture
ProPharma values diversity, equity, inclusion, and fosters an innovative, collaborative, and entrepreneurial work environment where employees can be authentic and empowered.
Company information
ProPharma is a 20-year-old global Research Consulting Organization specializing in biotech, med device, and pharmaceutical sectors, offering end-to-end consulting across product lifecycles with expertise in regulatory sciences, clinical research, quality, pharmacovigilance, and R&D technology.
Team overview
The candidate will be a permanent team member working remotely within the EU, collaborating closely with clients and internal units on Cell & Gene Therapy projects.
Job location and travel
Remote based anywhere in the EU with required travel to client sites.
Unique job features
This role uniquely combines remote work flexibility with critical on-site client engagement and involves cutting-edge projects in Cell & Gene Therapy quality and compliance.
Company overview
ProPharma is a global leader in providing comprehensive compliance, regulatory, and quality solutions to the pharmaceutical, biotechnology, and medical device industries. They generate revenue through consulting services, helping companies navigate complex regulatory landscapes, ensuring product quality, and achieving compliance with international standards. Founded in 2001, ProPharma has grown through strategic acquisitions and global expansion, establishing a strong presence in key markets worldwide. Their expertise spans from early development through post-approval, making them a trusted partner in bringing safe and effective products to market.
How to land this job
Position your resume to highlight your extensive experience in ATMPs and Cell & Gene Therapy, emphasizing your expertise in GMP-regulated manufacturing techniques such as CAR-T, iPSCs, and MSCs.
Showcase your qualifications as a Qualified Person (QP) authorized under European Directive 2001/83/EC, including your involvement in QP batch certification and regulatory inspections.
Emphasize your skills in quality and compliance management, risk assessment tools like FMEA and HACCP, and your ability to lead and consult on complex GxP projects across clinical and commercial settings.
Apply through multiple channels including ProPharma's corporate careers page and LinkedIn to maximize your visibility and application success.
Connect with current ProPharma consultants or team members in the Cell&Gene/ATMP division on LinkedIn, using ice breakers such as asking about their latest projects in ATMP quality systems or inquiring how they stay updated with evolving regulatory requirements.
Optimize your resume for ATS by incorporating key terms from the job description like 'ATMP', 'Qualified Person', 'GMP', 'risk assessment', and 'quality management system' to ensure your resume passes initial automated screenings.
Consider using Jennie Johnson's Power Apply feature to automate tailored resume customization, multi-channel applications, and LinkedIn networking outreach, allowing you to focus your energy on preparing for interviews and strategic career moves.
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