For the past 25 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. 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 to join the team in the EU to support a range of clients primarily operating in the Blood & Plasma 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 EU. This role can be performed remotely from any of our EU hubs (Netherlands ideally but we are open to Sweden or Germany also) with the provision you can travel as and when the role requires for critical aspects needed to perform the project.
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/commercial stages.
They will be responsible for providing independent consultation with clients and project leadership to a range of challenging and fascinating projects across the Blood & Plasma biological space.
Ideally 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 Blood & Plasma QA field
Ensure the successful execution of key projects and ensure profitability
Keep pace with the regulatory and technological changes in the Blood & Plasma 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 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 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:
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 across the Quality assurance space (can be made up of various areas but with a significant focus on QA)
Proven experience working with Blood or Plasma products is key ideally as a Qualified Person
Active experience (or recent) working as a Qualified person (QP) within the EU would be highly preferred
Extended experience across QA which includes GDP activities (Responsible Person) would be 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 (FMEA, FTA, HACCP, Gap Assessment etc.)
Ideally skilled as an auditor
Fluent in English & any other EU language would be preferred (English alone is still sufficient)
Able to work remotely but travel as and when required
#LI-DNI
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.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***