Overview
Senior Qualified Person Jobs in Leiden, South Holland, Netherlands at Meet Life Sciences
Title: Senior Qualified Person
Company: Meet Life Sciences
Location: Leiden, South Holland, Netherlands
About the Company
Senior Qualified Person – Sterile Products & Batch Release
About the Role
The Senior Qualified Person (QP) is legally responsible for certifying batches of medicinal products before release to market (human and veterinary). The role is responsible for managing a key product portfolio with a focus on batch release compliance, ensuring all quality, regulatory, and documentation requirements are met to enable timely release to licensed global markets. The Senior Qualified Person leads and oversees a team of Quality professionals within the Quality function, providing guidance, support, and development to foster high performance, operational excellence, and continuous improvement. Working closely with key personnel (e.g., Heads of Production, Quality Control, Quality Assurance, and Supply Chain), the Senior Qualified Person ensures that manufacturing and import activities operate in full compliance with EU-GMP (Volume 4), relevant EU directives (including 2001/83/EC and 2011/62/EU), and applicable Dutch legislation, including the Medicines Act (Geneesmiddelenwet) and Opium Act (Opiumwet), while fulfilling public service obligations. The Senior Qualified Person is accountable for ensuring continuous compliance with all applicable legal and regulatory requirements. Duties may be delegated; responsibility cannot. The Senior Qualified Person must be named on the organisation’s Manufacturing and Import Authorisation (MIA).
Reporting Structure
- Reports to: Head of Qualified Person, EU Region
- Deputy during absence: Senior Qualified Person
Key Responsibilities
- Quality & Compliance Leadership
- Perform Qualified Person certification for assigned medicinal products, ensuring full compliance with regulatory and quality requirements.
- Certify each finished medicinal product batch for release, confirming it has been manufactured and tested in accordance with GMP, the Marketing Authorisation, and all applicable EU and Dutch legislation.
- Ensure QP certification activities are conducted in accordance with the organisation’s MIA and comply fully with EU-GMP Volume 4 and Annex 16 requirements.
- Review, approve, and sign change controls, process validation protocols and reports, analytical transfer activities, SOPs, Quality Technical Agreements (QTAs), Annual Product Quality Reviews (APQRs), and other quality documentation.
- Draft, review, approve, and sign QP Declarations required for regulatory submissions and inspections.
- Ensure GMP-related customer complaints are appropriately managed and support associated investigations.
- Support implementation and maintenance of GMP requirements and Qualified Person responsibilities within the Quality Management System (QMS).
- Ensure appropriate initial and ongoing GMP training programmes are maintained.
- Project & Product Lifecycle Management
- Oversee planning, coordination, and delivery of assigned projects, ensuring objectives, timelines, and regulatory requirements are consistently achieved.
- Lead New Product Introduction (NPI) activities, including technological transfers and analytical method transfers.
- Collaborate closely with NPI Project Managers to support successful product launches within agreed timelines.
- Manage qualification and approval activities for new Contract Manufacturing Organisations (CMOs) supporting product introductions.
- Team Leadership
- Provide leadership, coaching, and direction to Quality team members.
- Drive effective performance management, employee development, succession planning, and continuous improvement initiatives.
- Foster a culture of quality, compliance, accountability, and collaboration.
- Inspection & Audit Support
- Participate in and support risk assessments, internal audits, supplier audits, customer audits, and regulatory inspections.
- Act as a key quality representative during interactions with competent authorities and regulatory agencies.
- Product Recall Management
- Coordinate and execute medicinal product recall activities when required.
- Ensure timely escalation and communication of quality and compliance risks.
Authority
- The Senior Qualified Person has the authority to:
- Represent the organisation in interactions with national and international competent authorities and ensure accurate and timely provision of required information.
- Initiate product recall procedures, following appropriate internal notification and regulatory approval processes.
- Inform competent authorities of any deviation from, or violation of, the provisions of the Opium Act.
- Suspend operations when, in their professional judgement, activities do not comply with the Quality Management System, applicable legislation, Marketing Authorisations, or authorised activities under the MIA.
- Approve or reject raw materials, packaging materials, intermediates, and finished medicinal products in accordance with GMP requirements.
- Notify competent authorities of any suspicion of falsified medicinal products in coordination with the Marketing Authorisation Holder (MAH).
Regulatory Requirements
In accordance with Directive 2001/83/EC, Article 48 (as amended): The Qualified Person must be accepted by the competent authorities in the Netherlands and listed on the Manufacturing and Import Authorisation (Fabrikantenvergunning).
Key Skills & Competencies
- Demonstrated experience managing complex pharmaceutical projects.
- Proven people leadership and team management experience.
- Strong technical expertise in EU GMP regulations, guidelines, and quality systems.
- Experience operating within an EU regulatory-approved Quality Management System.
- Highly collaborative with the ability to work effectively across Regulatory Affairs, Pharmacovigilance, Supply Chain, Quality, Manufacturing, Commercial, and external partner functions.
- Self-motivated, responsive, results-oriented, and capable of working independently.
- Strong GMP and GDP auditing knowledge and practical experience, including hosting and conducting audits.
- Excellent communication, influencing, and stakeholder management skills.
- Positive, flexible, and team-oriented approach.
- Ability to work effectively under pressure in a fast-paced environment.
Qualifications & Experience
- Eligible to act as a Qualified Person (QP) under Directive 2001/83/EC, as amended.
