Qualified Person

Hyper Recruitment Solutions; Leiden; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Flexible working arrangements

Job summary

Hyper Recruitment Solutions is seeking a Senior Qualified Person to lead batch release and ensure regulatory compliance for a high-profile pharmaceutical portfolio. The role focuses on EU GMP compliance, Dutch legislation, and international requirements, with strategic influence on product quality and global markets.

You will coordinate regulatory obligations, authorise batch releases, manage change controls, and drive continuous improvement within a collaborative team.

Qualifications

• Proven experience as a certifying Qualified Person.
• Extensive knowledge of EU GMP standards, regulations, and guidelines.
• Experience leading teams and overseeing complex projects in pharma.

Responsibilities

• Certify medicinal product batches for release under GMP and EU directives.
• Oversee release of drug and PCC products ensuring regulatory compliance.
• Lead and develop a quality team and collaborate with cross-functional functions.

Skills

Leadership

Quality management

Regulatory affairs

EU GMP knowledge

Education

Degree in Pharmaceutical Chemistry/QA/Quality Management

Tools

GMP documentation

Job description

We are currently looking for a Senior Qualified Person to join a leading pharmaceutical organisation that specialises in complex medicinal products, based in a location with a global reach. An exciting opportunity for a seasoned QP professional to lead batch release and ensure compliance for a high-profile product portfolio, within a company committed to quality and regulatory excellence. This role offers a chance to influence product quality at a strategic level and work with a dynamic, collaborative team committed to maintaining the highest standards across markets worldwide.

This position is integral to the company's compliance with EU-GMP standards, Dutch legislation, and international requirements, and involves overseeing project management, quality assurance activities, and team leadership within the quality function. The Senior QP will coordinate regulatory obligations, authorise batch releases, and support continuous improvement initiatives, all while working closely with key internal and external stakeholders to uphold the company's reputation for quality and safety.

KEY DUTIES AND RESPONSIBILITIES

Your duties as the Senior Qualified Person will be varied however the key duties and responsibilities are as follows:

• Legally responsible for certifying medicinal product batches for release in accordance with GMP, EU directives, Dutch legislation, and marketing authorisations.
• Oversee and manage the certification and release of drug products and PCC products, ensuring full compliance with all relevant regulatory and quality standards.
• Lead and develop a team of quality professionals, fostering a culture of high performance, continuous improvement, and regulatory adherence.
• Collaborate with cross-functional teams including production, quality control, regulatory affairs, and supply chain to ensure operational compliance and successful product launches.
• As the Senior QP, you will manage change controls, perform risk assessments, approve validation protocols, and ensure audit and inspection readiness.

ROLE REQUIREMENTS

To be successful in your application to this exciting role as the Senior Qualified Person, we are looking to identify the following on your profile and past history:

• A Degree or higher level in a relevant field (e.g., Pharmaceutical Chemistry, Quality Assurance, Quality Management).
• Proven experience as a certifying Qualified Person, with extensive knowledge of EU GMP standards, regulations, and guidelines.
• Demonstrated leadership skills with experience managing teams and overseeing complex projects within the pharmaceutical industry, particularly involving sterile and narcotic products.
• Eligibility to act as a Qualified Person under EC/2001/83 Directive and engagement with both manufacturing and regulatory authorities in the EU.

WHAT’S IN IT FOR YOU?

Join a forward-thinking organisation committed to excellence and continuous development. You will have the opportunity to influence global product compliance, work alongside industry experts, and contribute to high-impact projects within a supportive and innovative environment. The role offers flexible working arrangements, ongoing training, and a chance to develop your leadership skills within a highly regulated industry.

Key Words: Qualified Person / QP / Batch Release / GMP / EU Regulations / Pharmaceutical Quality / Leadership / Compliance / Project Management /

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.