Senior Compliance & Quality Assurance Consultant - Qualified Person - ATMP in Edinburgh

Company profile

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.

The role

We are currently searching for a Senior Compliance & Quality Assurance Consultant – ATMP – Qualified Person to join the team in the UK to support a range of clients primarily operating in the ATMP/Cell and Gene therapy area. This function is to be a permanent member of the team at ProPharma and will spearhead several fascinating and scientifically rewarding projects within the UK & EU. This role can be performed remotely from any UK location with the provision you can travel as and when the role requires when performing key projects for our clients.

Essential Functions Include:

• The Senior Compliance & Quality Assurance Consultant – ATMP – Qualified Person position is primarily responsible for being a key Subject matter expert in assigned areas of quality and compliance (Q&C) for Cell& Gene Therapy medicinal product investigational/commercial.
• They will be responsible for providing independent consultation with clients and project leadership to a range of challenging and fascinating projects across the Cell&Gene/ATMP Q&C space.
• Be authorized to work as a Qualified Person in relation to such tasks like QP batch certification, GxP auditing, developing Quality Management Systems (QMS) etc.
• Work as a Responsible Person (GDP) as and when required.
• Support commercial activities from an SME perspective within the ATMP Q&C field.
• Ensure the successful execution of key projects and ensure profitability.
• Keep pace with the regulatory and technological changes in the Cell&Gene/ATMP Q&C 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 clinical/commercial processes 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 Cell&Gene/ATMP Q&C 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.
• Directly engage with employees at all levels to educate on compliance and quality assurance to drive continuous improvement.
• Other duties as assigned.

Qualified candidates must have:

• Must be educated to a BSc or higher within a life-sciences discipline which allows you to be a Qualified Person.
• At least 10-15 years working within the life-sciences area ideally exposed to various therapies and disciplines within Quality Assurance.
• Must be able to demonstrate key experience working in the ATMP/CGT field ideally as a Qualified Person.
• Extended experience across QA which includes GDP activities (Responsible Person) would be preferred but not essential if you are a Qualified Person.
• Knowledge of the main manufacturing techniques for cell and gene therapy products 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.).
• Fluent in English.
• Able to work remotely but travel as and when required.

Additional Information

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.