Freelance Qualified Person (QP)

About the Role

We are seeking an experienced Qualified Person (QP) to join a growing pharmaceutical manufacturing site in Warsaw. This role is critical in ensuring product compliance, quality oversight, and batch certification in line with EU GMP requirements.

Experience in sterile manufacturing is highly desirable, though not essential - candidates with a strong GMP pharmaceutical background will also be considered.

 

Key Responsibilities

• Perform QP certification and release of medicinal product batches
• Ensure compliance with EU GMP and regulatory requirements
• Provide quality oversight across manufacturing and quality operations
• Support deviation, CAPA, and change control processes
• Liaise with regulatory bodies and internal stakeholders
• Participate in site inspections and audits
• Provide guidance on quality and compliance matters across the site

 

Working Hours & Flexibility

• Rotating shift pattern agreed with the QP team and Site Manager:
• 06:00 – 14:00
• 07:00 – 15:00
• 08:00 – 16:00
• Monday to Friday core working week
• Planned one Saturday production shift per month
• Night shift duty: approx. 2-3 times per week (on a rota basis - approx. 1 call out every two months on average)

 

Requirements

• Eligible to act as a Qualified Person under EU Directive 2001/83/EC
• Strong working knowledge of GMP regulations
• Experience in pharmaceutical manufacturing environments
• Sterile manufacturing experience desirable but not essential
• Strong attention to detail and decision-making capability
• Excellent communication and stakeholder management skills

 

What’s on Offer

• Competitive salary and bonus payments
• Structured and predictable shift rotation
• Opportunity to work in a dynamic and expanding manufacturing site
• Exposure to a wide range of products and processes
• Collaborative and supportive team environment

 

Apply Now

If you are a Qualified Person looking for your next opportunity in Warsaw, we would love to hear from you!

As part of a significant operational expansion we are delighted to be exclusively partnering with a market leading global brand and supporting the hire of a new Laboratory Validation Officer.

This person will focus predominantly on method validation activities from bench to HPLC. There may be the need for some degree of method development.

Working in a small team this role must have independent and “can do” focus.

The opportunities in the business for development and progression are strong and they welcome a proactive and ambitious attitude.

For further details please contact Mark Bux-Ryan

 

Key experience

• Previous experience in method validation of HPLC
• Pharmaceutical (or healthcare/nutraceutical) GMP experience
• Any method development experience is advantageous
• Problem solving mindset with ability to work independently
  

As part of a significant operational expansion and investment into the Quality team, we are delighted to be exclusively partnering with a market leading global brand and supporting the hire of a new QA Officer, with a systems focus.

The successful hire will work within the QMS team and will focus their time around managing and conducting internal audits, as well as writing change controls, amongst other activities. Given the size of the team and the expansion of operations, the need for working quickly and confidently across all levels is critical.

The opportunities in the business for development and progression are strong and they welcome a proactive and ambitious attitude.

For further details please contact Mark Bux-Ryan.

 

Key experience

• Previous experience in managing quality systems / QMS
• Knowledge of QPULSE is an advantage
• Pharmaceutical (or healthcare/nutraceutical) or food manufacturing GMP experience essential
• Must have experience in managing and writing change controls
• Internal auditing experience essential

SharePoint Consultant (Junior–Mid) - Contract - 6 Months - Fully Remote - Umbrella Inside IR35 - No Sponsorship

 

About the Role

We’re looking for a SharePoint Consultant with a strong business analysis mindset to support the delivery of SharePoint and Microsoft 365 solutions across multiple business units.

This role sits at the intersection of business and technology ideal for someone who enjoys working with stakeholders, gathering requirements, and translating them into clear, structured deliverables for technical teams.

If you have 2–3 years of SharePoint experience and are looking to grow into a more consultative role, this is a great opportunity to build your career.

 

What You’ll Be Doing

• Work with business stakeholders to gather, analyse, and document SharePoint requirements
• Translate business needs into functional and technical specifications
• Partner with project and technical teams to support solution delivery
• Produce detailed project documentation and requirement reports (Excel-based templates)
• Participate in stakeholder meetings, workshops, and discovery sessions
• Ensure requirements are clearly defined, structured, and aligned to business outcomes
• Support ongoing SharePoint initiatives and improvements

 

What We’re Looking For

• 2–3 years of experience with SharePoint (Online preferred)
• Strong business analysis or requirements gathering skills
• Ability to translate business needs into technical requirements
• Experience creating structured documentation (especially Excel-based reporting/templates)
• Familiarity with:
• SharePoint lists, libraries, and document management
• Permissions and basic workflows
• Strong communication skills and confidence working with non-technical stakeholders
• Highly organized with excellent attention to detail

 

Nice to Have

• Exposure to Power Platform (Power Automate / Power Apps)
• Experience working on projects (Agile or Waterfall)
• Understanding of SharePoint governance or information architecture

Oncology Clinical Development | Early Phase Biotech

A rapidly growing clinical-stage biotechnology organization is seeking two experienced Senior Clinical Project Managers / Senior Clinical Study Managers to support the execution of global oncology clinical trials across early and late-stage development.

These individuals will play a critical role in leading complex international studies, including First-in-Human (FIH) programs involving novel biologic therapies. This is an opportunity to join a highly collaborative and scientifically driven clinical operations team focused on advancing innovative oncology treatments in a fast-paced development environment.

 

Key Responsibilities

Global Clinical Trial Leadership

• Lead the end-to-end operational execution of global Phase I–III oncology studies from startup through closeout
• Oversee timelines, budgets, quality, and cross-functional deliverables to ensure successful study execution
• Support protocol development, country/site activation strategies, enrollment planning, and study reporting activities
• Drive operational excellence across complex oncology programs, including FIH and registration-enabling studies

Study Oversight & Vendor Management

• Manage CROs and external vendors across monitoring, data management, imaging, laboratories, ePRO, and related services
• Proactively identify operational risks and implement mitigation strategies
• Ensure inspection readiness and compliance with ICH-GCP, SOPs, and global regulatory requirements
• Oversee forecasting, accruals, budget tracking, and change order management

Cross-Functional Collaboration

• Lead global study team meetings and facilitate effective decision-making across stakeholders
• Partner closely with Clinical Development, Medical, Regulatory, Biometrics, Safety, and external collaborators
• Build and maintain strong relationships with investigators, academic institutions, and key external partners

 

Qualifications

Required Experience

• 10+ years of clinical operations experience within biotech, pharma, or CRO environments
• 5+ years leading global oncology clinical trials
• Strong experience supporting early phase oncology studies, including FIH, dose escalation, and expansion cohorts
• Demonstrated success managing global CROs and multi-vendor clinical programs
• Deep understanding of oncology drug development and complex clinical trial operations
• Strong knowledge of ICH-GCP and global regulatory standards
• Excellent leadership, communication, and stakeholder management skills
• Ability to operate independently in a fast-paced and evolving environment

Preferred Background

• Experience with immuno-oncology, targeted therapies, or solid tumor indications
• Exposure to registration-directed or late-stage studies
• Prior experience within small or emerging biotech companies
• Advanced scientific degree and/or project management certification preferred

 

Why This Opportunity?

• High visibility role within a growing oncology organization
• Opportunity to lead innovative global oncology studies from early development onward
• Collaborative, science-driven culture with strong executive exposure
• Meaningful impact on cutting-edge therapies for patients with unmet medical needs