CGT/ATMP Senior Consultant – Qualified Person

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

We are currently searching for a CGT/ATMP Senior Consultant – Qualified Person who will be key in supporting a range of ProPharma client’s who operate in the Cell & Gene therapy (ATMP) area. This function is to be a permanent member of the team at ProPharma and will spearhead a number of fascinating and scientifically rewarding projects within the EU. This role can be performed from any EU location remotely coupled with subsequent travel to our client’s sites when required.

Essential Functions Include:

• The Senior Consultant Compliance, Quality Assurance (CQA) position is primarily responsible for being a key Subject matter expert in assigned areas of quality assurance and regulatory/GxP.

• They will be responsible for providing Independent consultation with clients and project leadership to a range of challenging and fascinating projects across the CQA space.

• Be authorized to work under the PPG MIA license as a Qualified Person in relation to such tasks like QP batch certification, GxP auditing, developing Quality Management Systems (QMS) etc.

• Ensure the successful execution of key projects and ensure profitability

• Keep pace with the regulatory and technological changes in the CQA field

• Be a critical team member who contributes to the implementation and successful execution of risk-based and phase appropriate GxP projects.

• Act as the SME within the commercial process with clients as required and identify scope and effort required to successfully address client needs.

• Actively promote CQA services within the industry across various platforms

• Promote continual improvement regarding customer satisfaction with emphasis on CQA consulting services.

• Provide CQA specific training to clients and associates within other business units.

• Provide support to clients and all functional units of ProPharma as GxP issues such as deviations and non-conformances arise.

• Provides consultation for the implementation of proper CAPA to resolve deviations and non-conformances. Also, is responsible for ensuring compliance of company operations to quality principles and participation in the development of quality systems through SOP writing and training.

• Directly engages with employees at all levels to educate on compliance and quality assurance to drive continuous improvement.

• Other duties as assigned

Qualified candidates must have:

• At least 10 years of experience in Biotech and/or ATMPs/Cell & Gene Therapy

• Knowledge of the main manufacturing techniques for cell and gene therapy products (CAR-T, iPSCs, TILs, MSCs etc) in a GMP regulated environment

• Familiarity with ATMPs/Cell & Gene manufacturing facility qualifications and validations

• Familiarity with risk assessment tools (FMEA, FTA, HACCP, Gap Assessment etc)

• Have participated in the preparation of/participation in at least one regulatory inspection

• Available to be onsite (the other time remote) for 40%-50% per month depending on the requirements at the time

• Fluent in English

• Authorisation as QP for ATMPs for Europe (according to Directive 2001/83/EC)

• Familiarity with the authorisation procedure for GMO manufacturing sites in Europe is a plus