Senior Compliance & Quality Assurance Consultant - Permanent position

ProPharma provides consulting solutions across regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology to support biotech, medical device, and pharmaceutical organizations throughout the product lifecycle.

The role

We are currently searching for a Senior Compliance & Quality Assurance Consultant to join the team in the EU to support a range of clients primarily operating in the Blood & Plasma therapy area. This is a permanent role within the ProPharma team and will spearhead several fascinating and scientifically rewarding projects within the EU.

Essential Functions Include:

• The Senior Compliance & Quality Assurance Consultant position is primarily responsible for being a key subject matter expert in assigned areas of quality and compliance (Q&C) for Blood & Plasma products in investigational and commercial stages.
• Provide independent consultation with clients and project leadership across a range of challenging projects in the Blood & Plasma biological space.
• Ideally act as a Qualified Person in relation to tasks such as QP batch certification, GxP auditing, and developing Quality Management Systems (QMS).
• Work as a Responsible Person (GDP) as required.
• Support commercial activities from an SME perspective within the Blood & Plasma QA field.
• Ensure the successful execution of key projects and ensure profitability.
• Keep pace with regulatory and technological changes in the Blood & Plasma Q&C field.
• Contribute to the implementation and successful execution of risk-based and phase-appropriate GxP projects.
• Act as the SME within clinical and commercial processes with clients as required and identify scope and effort needed to address client needs successfully.
• Actively promote CQA services within the industry across various platforms.
• Promote continual improvement regarding customer satisfaction with emphasis on CQA consulting services.
• Provide Blood & Plasma 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:

• BSc or higher within a life sciences discipline that allows you to be a Qualified Person.
• At least 10–15 years of experience within the life sciences area, ideally across quality assurance with a significant focus on QA.
• Proven experience working with Blood or Plasma products, ideally as a Qualified Person.
• Active or recent experience working as a Qualified Person (QP) within the EU is highly preferred.
• Extended experience across QA including GDP activities as a Responsible Person is preferred but not essential.
• Knowledge of the main manufacturing techniques for Blood and Plasma therapy products in a GMP-regulated environment.
• Familiarity with Blood & Plasma manufacturing facility qualifications and validations.
• Familiarity with risk assessment tools such as FMEA, FTA, HACCP, and gap assessment.
• Ideally skilled as an auditor.
• Fluent in English; any other EU language would be preferred, though English alone is sufficient.