Qualified Professional, Leiden

The Senior Qualified Person is legally responsible for certifying batches of medicinal products before release to market (human and veterinary). Responsible for managing assigned commercial and strategic projects with a focus on batch release compliance, ensuring all quality, regulatory, and documentation requirements are met to enable timely release to licensed global markets.Lead and oversee a team of Quality professionals within the Quality function. Guide, support, and develop the team, fostering high performance, operational excellence, and continuous improvement.

Working with key personnel (e.g., Heads of Production, QC, QA, and Supply Chain), the Senior Qualified Person must ensure the manufacturer/importer operates 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 ensuring public service obligations are met.

The Senior Qualified Person must ensure that the company and its activities remain in continuous compliance with legal and regulatory requirements. The Senior Qualified Person may delegate duties but not responsibilities. The Senior Qualified Person must be listed on the company’s Manufacturing and Import Authorisation (MIA).

Place Within the Organisation Direct reporting line:

Head Qualified Person EU Region Acting representative during absence:

Senior Qualified Person

Duties and Responsibilities Oversee the planning, coordination, and delivery of assigned projects, ensuring objectives, timelines, and regulatory requirements are consistently met. Lead New Product Introduction (NPI) activities, including oversight of technological and analytical method transfers.Collaborate closely with NPI Project Managers to ensure successful product launches within agreed timelines. Manage the qualification and approval of new Contract Manufacturing Organisations (CMOs) associated with new products. Perform QP certification for commercial products, ensuring full compliance with regulatory and quality requirements.Provide leadership and direction to team members, ensuring effective performance management, development, and alignment with organisational and compliance standards. 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 is performed in line with the company’s MIA and fully complies with EU GMP Volume 4, Annex 16 requirements for QP certification and batch release. Review, approve, and sign off change controls, process validation protocols/reports, analytical transfer activities, SOPs, QTAs, APQRs, and annual reports.Participate in the execution of risk assessments, internal and external audits, and regulatory inspections. Draft, review, approve, and sign QP Declarations as required for regulatory purposes. Ensure GMP-related customer complaints are effectively managed and support associated investigations. Ensure and/or support implementation and maintenance of GMP aspects and the role of the Qualified Person within the Quality Management System, including initial and continuous training of personnel.Coordinate and promptly execute medicinal product recall operations as required.

Authority Represent the company in interactions with national and international competent authorities and ensure accurate and timely provision of required information. Initiate product recall procedures—after informing the Executive Board and, where applicable, the QPPV and/or MAH—subject to agreement and approval by the Competent Inspection Authorities.Inform the competent authorities of any deviation from, or violation of, the provisions of the Opium Act. Exercise the authority to suspend operations when, in his/her professional judgement, activities are not compliant with the company’s Quality Management System, applicable international and national legislation, the product’s Marketing Authorisation, or the authorised activities specified in the MIA.Authorise the release or rejection of raw materials, packaging components, intermediates, and finished medicinal products in accordance with GMP requirements. Notify the competent authorities of any suspicion of falsified medicinal products in agreement with the MAH.

Legal Requirements According to Directive 2001/83/EC Article 48 (as amended from time to time)

The Qualified Person must be accepted by the competent authorities in the Netherlands and subsequently be listed on the Manufacturing and Import Authorisation (“Fabrikantenvergunning”).

Key Skills Experience managing projects. Experience leading and developing teams. Strong technical knowledge of EU GMP regulations and guidelines, with experience operating within an EU regulatory-approved Quality Management System. Highly collaborative with regular interaction across senior management, Regulatory Affairs, QPPV, Supply Chain, site-based QA, distributors, testing laboratories, warehouses, sales departments, customers, and regulators.Ability to work independently; self-driven, responsive, and results-oriented. GMP and GDP auditing knowledge and practical experience, both hosting and performing audits. Strong interpersonal skills with a positive and flexible attitude. Ability to work effectively under pressure in a fast-paced environment.

Other Qualification Requirements Eligible to act as a Qualified Person (QP) under EC Directive 2001/83 as amended. Experience acting as a certifying QP. Experience within Quality Assurance for sterile products. Experience within Quality Assurance for narcotic products is advantageous. Minimum C1-level proficiency in Dutch and English..