Back to job search

Qualified Person (QP)

Warsaw, Poland

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!

Apply Now

Discipline

Job Ref

PR/030283

Published

11 days ago

Expiry

29 Jun 2026 23:59

Share job

LinkedInTwitterFacebookWhatsAppEmail

Submit your application

Other Related Jobs

Interim Lead Buyer

Frodsham, UK
Competitive Rate

We are exclusively partnered with a global CDMO that, after recent investment, is going through an exceptional period of transition due to increasing customer demand.

As part of this transition we have been supporting the supply chain and procurement teams expand, with experienced professionals who have the capability and desire to manage this change.

This new hire is for a Lead Buyer. A critical role that will be responsible for hands on procurement and purchasing activities, as well as taking a lead on managing both internal and external relationships. As part of a small team, this role will take on a more senior role in managing expectations and driving progress to ensure that customer demand is met.

This is an outstanding opportunity for career development, as you will have a significant opportunity to influence and own process changes. As the business continues to expand over the next 12 months, this position needs to be integral to how this gets shaped.

This role has the potential to be hybrid, with two days working from home.

 

Key experience:

  • Established experienced in purchasing/procurement activities within an FMCG environment
  • Experience within pharmaceuticals, healthcare or food manufacturing is a strong advantage
  • Must have experience within manufacturing procurement
  • Experience of managing and experiencing change within an operational setting
  • Exceptional stakeholder management skills

Lead Buyer

Frodsham, UK
c.£50-65,000 (doe)

We are exclusively partnered with a global CDMO that, after recent investment, is going through an exceptional period of transition due to increasing customer demand.

As part of this transition we have been supporting the supply chain and procurement teams expand, with experienced professionals who have the capability and desire to manage this change.

This new hire is for a Lead Buyer. A critical role that will be responsible for hands on procurement and purchasing activities, as well as taking a lead on managing both internal and external relationships. As part of a small team, this role will take on a more senior role in managing expectations and driving progress to ensure that customer demand is met.

This is an outstanding opportunity for career development, as you will have a significant opportunity to influence and own process changes. As the business continues to expand over the next 12 months, this position needs to be integral to how this gets shaped.

This role has the potential to be hybrid, with two days working from home.

 

Key experience:

  • Established experienced in purchasing/procurement activities within an FMCG environment
  • Experience within pharmaceuticals, healthcare or food manufacturing is a strong advantage
  • Must have experience within manufacturing procurement
  • Experience of managing and experiencing change within an operational setting
  • Exceptional stakeholder management skills

Senior Lead Buyer

Cheshire, UK

Lead Buyer

We are exclusively partnered with a global CDMO that, after recent investment, is going through an exceptional period of transition due to increasing customer demand.

As part of this transition we have been supporting the supply chain and procurement teams expand, with experienced professionals who have the capability and desire to manage this change.

This new hire is for a Lead Buyer. A critical role that will be responsible for hands on procurement and purchasing activities, as well as taking a lead on managing both internal and external relationships. As part of a small team, this role will take on a more senior role in managing expectations and driving progress to ensure that customer demand is met.

This is an outstanding opportunity for career development, as you will have a significant opportunity to influence and own process changes. As the business continues to expand over the next 12 months, this position needs to be integral to how this gets shaped.

This role has the potential to be hybrid, with two days working from home.

Key experience:

  •            Established experienced in purchasing/procurement activities within an FMCG environment
  •            Experience within pharmaceuticals, healthcare or food manufacturing is a strong advantage
  •            Must have experience within manufacturing procurement
  •            Experience of managing and experiencing change within an operational setting
  •            Exceptional stakeholder management skills

 Buyer, procurement, purchasing, lead, manager, supervisor, specialist, FMCG, manufacturing, pharmaceutical, nutraceutical, supplement, food, beverage, healthcare, stakeholder

Pharmacometrics Director - AI/ML

Germany
€100-150,000

I’m supporting a major biopharmaceutical company that is building out its Quantitative Clinical Pharmacology capability and looking for an experienced Pharmacometrics & AI/ML Lead. This is a strategic role for someone eager to push the boundaries of model‑informed and machine‑learning driven drug development.

This position is perfect for someone who thrives at the intersection of advanced pharmacometrics, AI/ML innovation and clinical strategy. You will lead the vision and execution of AI‑enabled modelling approaches across the organisation’s development portfolio.

 

Key Responsibilities

In this role, you will drive and deliver:

  • A robust AI/ML and Pharmacometrics strategy to guide dose optimisation, extrapolation, study design and regulatory planning.
  • Application and evaluation of emerging technologies relevant to quantitative clinical pharmacology.
  • Hands‑on delivery of AI/ML models, population PK/PD analyses, exposure–response modelling, and clinical trial simulations.
  • High‑quality documentation including regulatory‑ready analysis plans and reports.
  • Management of external vendors and the opportunity to internalise and grow AI/ML and PMx capabilities.
  • Scientific and technical development of team members in modern PMx and AI‑driven modelling approaches.
  • Engagement with global regulatory agencies, including contribution to discussions across therapy areas.
  • Close collaboration with project leads to ensure seamless integration of modelling outputs.

 

We are looking for candidates with:

  • PhD or MD in pharmaceutical sciences, engineering, statistics or a related field.
  • 5+ years of industry experience in pharmacometrics, including significant hands-on AI/ML application in drug development.
  • Strong background in population PK/PD, disease progression modelling, and simulation-based decision support.
  • Technical skills in R, Python, Matlab, NONMEM or equivalent PMx software environments.

Pharmacometrics Team Lead

Germany
€100-150,000

I’m supporting a biopharma organisation looking to hire an experienced leader to head up a team focused on advanced PK/PD modelling and simulation sciences.

This role sits at the heart of R&D, shaping strategy and guiding key decisions across discovery and development.

 

What you’ll do:

  • Lead and develop a team of quantitative scientists and pharmacometricians
  • Drive modelling strategy across multiple programmes
  • Work hands‑on on priority projects (popPK/PD, exposure–response, simulations)
  • Develop high‑quality analysis plans and regulatory‑ready documentation
  • Oversee external partners and support regulatory interactions
  • Champion model‑informed drug development across the business

 

What you’ll need:

  • PhD/MD in a quantitative or scientific discipline
  • 8+ years’ experience in PK/PD modelling roles
  • Line management or leadership experience
  • Strong background in PK/PD, disease modelling, and simulations
  • Expertise with tools such as NONMEM or R
  • Familiarity with PBPK, QSP, Bayesian methods, and modern data‑driven approaches

Director, PBPK Modelling and Simulation

United Kingdom
€100-150,000

I’m working with a global biopharma company seeking an accomplished PBPK Lead to strengthen their Quantitative Clinical Pharmacology (QCP) function. This is a strategic scientific leadership role for someone who wants to shape modelling strategy and influence decision‑making across an exciting development pipeline.

The successful candidate will take ownership of the end‑to‑end Pharmacometrics strategy, ensuring that modelling insights directly guide project direction and development milestones.

 

Key aspects of the role include:

  • Setting the strategic direction for model‑informed drug development, driving decisions around dose selection, extrapolation, study design and paediatric planning.
  • Delivering hands‑on PBPK, QSP and clinical simulation work across multiple assets.
  • Converting complex model outputs into clear scientific recommendations for cross‑functional teams and senior stakeholders.
  • Producing high‑quality, regulatory‑appropriate analysis plans, reports and documentation.
  • Managing external vendors and supporting the build‑out of internal PMx capability.
  • Coaching team members and championing state‑of‑the‑art mechanistic modelling approaches.

 

My client is looking for someone with:

  • A PhD in Pharmaceutical Sciences, Engineering, Statistics or a related modelling discipline.
  • 5+ years of PBPK and QSP experience in the biotech/pharma sector.
  • Strong practical skills in PK‑Sim®/MoBi®, SimCyp®, GastroPlus®, Matlab and R.
  • Clear, confident communication skills and the ability to influence across multidisciplinary groups.