Qualified Person (QP) – Clinical Manufacturing & Quality Assurance - OPEN

SQUIPP; Ottignies; Hybrid; EUR 110,000 - 140,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

SQUIPP is seeking a Qualified Person (QP) to support clinical trial material release, GMP compliance and pharmaceutical quality operations near Ottignies, Belgium. You will work with R&D, QA, Regulatory Affairs and external partners to ensure compliant product release across markets.

The role offers hybrid working and exposure to international regulatory requirements, with potential final product release responsibilities for China for qualifying candidates.

Qualifications

• Fluent written and spoken English.
• Strong knowledge of EU GMP requirements and pharmaceutical quality systems.

Responsibilities

• Perform delegated QP activities, including batch release and certification of clinical trial materials.
• Review compliance with EU and Belgian GMP requirements, Product Specification Files and approved CMC information.
• Support the certification of materials received at the EU distribution hub.
• Assess and approve retest date extensions and study or country additions.
• Review and approve release documentation, including QP certificates and declarations.
• Support EU GMP equivalency assessments and certification documentation for biological APIs.
• Provide QP oversight of activities performed by manufacturing and packaging partners.
• Assess, investigate and approve deviations and change controls.
• Ensure CAPAs are implemented and verified for effectiveness.
• Review quality performance indicators and identify opportunities for improvement.

Skills

English language proficiency

Education

Master's degree in Pharmacy

Job description

Qualified Person (QP) – Clinical Manufacturing & Quality Assurance - OPEN

What if your next career move allowed you to take greater responsibility for the quality and release of medicines used in clinical trials around the world?

You've built your pharmaceutical expertise, developed your understanding of GMP requirements and learned how important quality decisions are to patient safety.

Now, you're ready to take the next step.

You want to move closer to critical batch release decisions, broaden your Quality Assurance responsibilities and collaborate with international pharmaceutical teams.

Imagine working in an environment where your judgment contributes directly to the compliance and availability of clinical trial medicines across different markets.

Where you can develop your expertise as a Qualified Person, take ownership of quality decisions and gain exposure to international regulatory requirements.

This could be your next challenge.

The opportunity

Our client is an international pharmaceutical organization supporting clinical development and manufacturing activities across multiple markets.

To strengthen its Quality Assurance and Qualified Person activities near Ottignies, Belgium, we're looking for a Qualified Person (QP) to support clinical trial material release, GMP compliance and pharmaceutical quality operations.

You'll work closely with Pharmaceutical R&D, Quality Assurance, Regulatory Affairs and external manufacturing and packaging partners.

Your responsibilities will combine two closely connected areas:

• Delegated QP activities: Supporting batch release and certification, reviewing quality documentation and ensuring clinical trial materials comply with applicable GMP and regulatory requirements.
  
• Quality Assurance: Managing quality events, supporting inspections and audits, overseeing external partners and contributing to continuous improvement.

For candidates with the required experience, the position may also include final product release for the Chinese market.

The role is open to relatively junior QP professionals looking to broaden their expertise, as well as more experienced candidates bringing international release experience.

The challenges you'll take on

1. Ensure the quality and compliance of clinical trial materials

You'll contribute to the release of clinical trial materials intended for use across different countries.

Your decisions will help ensure that medicines meet the required quality and regulatory standards before reaching clinical trial sites.

• Perform delegated QP activities, including batch release and certification of clinical trial materials.
• Review compliance with EU and Belgian GMP requirements, Product Specification Files and approved CMC information.
• Support the certification of materials received at the EU distribution hub.
• Assess and approve retest date extensions and study or country additions.
• Review and approve relevant release documentation, including QP certificates and declarations.
• Support EU GMP equivalency assessments and certification documentation for biological APIs.
• Provide QP oversight of activities performed by manufacturing and packaging partners.

2. Take ownership of pharmaceutical quality activities

You'll play an active role in maintaining an effective pharmaceutical quality system and resolving issues that may affect product quality.

• Assess, investigate and approve deviations and change controls.
• Ensure appropriate CAPAs are implemented, monitored and verified for effectiveness.
• Review quality performance indicators and identify opportunities for improvement.
• Escalate critical quality issues that could affect product safety, identity, strength, purity or quality.
• Contribute to quality improvement initiatives and cross-functional projects.
• Support the management of complaints and product redistribution activities when required.

3. S upport regulatory inspections and external partner oversight

Your responsibilities will extend beyond internal quality processes.

You'll interact with different quality organizations and external partners to maintain compliance throughout the clinical supply chain.

• Participate in regulatory inspections and inspection readiness activities.
• Support internal self-inspections and external partner audits.
• Collaborate with global and local QA teams, Regulatory Affairs and pharmaceutical development functions.
• Support quality oversight of manufacturing, packaging and distribution partners.
• Ensure appropriate management of retention and reference samples.
• Assist with product retrieval coordination and quality activities involving external collaborations and Expanded Access Programs.

4. Contribute to international product release

For candidates meeting the applicable experience requirements, the role may include an additional international responsibility.

• Perform final product release for China in accordance with applicable Chinese regulatory requirements.
• Collaborate with international Quality and Regulatory Affairs teams to support compliant product distribution.

This responsibility requires at least five years of practical experience in pharmaceutical R&D or production and quality management, including a minimum of one year in drug quality management.

Experience with China release is an advantage, not a requirement for the core QP position.

What you'll bring

We're looking for a pharmaceutical professional who combines scientific knowledge, a strong quality mindset and the ability to take responsibility for GMP compliance.

Your background

• A Master's degree in Pharmacy.
• At least one year of experience in a pharmaceutical environment.
• Knowledge of EU GMP requirements and pharmaceutical quality systems.
• Fluent written and spoken English.

Your technical expertise

You'll be comfortable working with, or ready to further develop your expertise in:

• GMP compliance and pharmaceutical quality systems.
• Batch release and QP certification activities.
• Deviations, investigations, change control and CAPA.
• Quality documentation and regulatory requirements.
• Clinical trial materials and pharmaceutical development activities.
• Quality oversight of external manufacturing and packaging partners.

Additional strengths

Experience in one or more of the following areas would be valuable:

• Investigational Medicinal Products (IMPs) and clinical trial supply.
• Regulatory inspections and GMP audits.
• International pharmaceutical manufacturing and distribution.
• Biological products or APIs.
• China-specific quality and product release requirements.

Your way of working matters just as much

You approach quality decisions with scientific rigor and sound judgment.

You can assess complex information, identify potential compliance risks and communicate your conclusions clearly.

You're comfortable collaborating with colleagues from different functions and cultures.

You take ownership of your responsibilities, follow through on quality issues and understand the importance of timely decisions in clinical development.

Above all, you recognize that every quality decision contributes to protecting patients and maintaining confidence in pharmaceutical products.

What success will look like

Your impact will be visible through:

• Clinical trial materials released in compliance with applicable GMP and regulatory requirements.
• Accurate and timely QP documentation and certification activities.
• Deviations and change controls assessed and managed effectively.
• CAPAs implemented and followed through to completion.
• Successful collaboration with internal quality teams and external manufacturing partners.
• Strong inspection readiness and reliable quality oversight.
• Continuous development of your QP expertise and increasing autonomy in quality decisions.

Develop your QP career

Build on your pharmaceutical experience and gain broader exposure to batch certification, clinical manufacturing and quality oversight.

Contribute to clinical development

Your work will help ensure that medicines used in clinical trials meet the required quality and regulatory standards.

Work in an international environment

Collaborate with Quality, Regulatory Affairs, Pharmaceutical R&D and external partners across different markets.

Broaden your technical expertise

Gain experience across GMP quality systems, clinical trial materials, inspections, audits and international release activities.

Take on meaningful responsibilities

Play an active role in quality decisions, investigations and compliance activities that directly affect pharmaceutical operations.

Build a long-term career

Join ClinChoice as a full-time employee under an initial one-year contract, with prospects for continued collaboration.

Where?

The position is based near Ottignies , Walloon Brabant, Belgium .

Hybrid working arrangement.

SQUIPP