Senior Quality Assurance Lead / QP & RP

Derks & Derks; Ankeveen; Presencial; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

Eurocept Pharmaceuticals in the Netherlands seeks a Senior Quality Assurance Lead / QP & RP to maintain and drive pharmaceutical quality and regulatory compliance. You lead the Quality team, coordinate audits, and ensure market release of products in line with GxP standards.

In this senior role you will develop the QMS, oversee CAPAs, change controls, batch certification, PQRs and stability studies, and support international collaborations and product launches while fostering a strong quality

Formación

• Master’s degree in a scientific discipline relevant to pharma.
• Extensive GMP/GxP knowledge and regulatory compliance.
• Experience leading quality initiatives and teams.
• Strong analytical and decision-making skills in QMS.
• Excellent communication and project management abilities.

Responsabilidades

• Lead QA activities and ensure QP & RP responsibilities meet regulatory standards.
• Develop, implement and improve the QMS, SOPs, CAPAs and change controls.
• Coordinate internal/external audits and support regulatory inspections.
• Oversee batch certification, PQRs, stability studies and narcotics management.
• Drive quality improvements, investigations and supplier/customer qualifications.

Conocimientos

Strategic leadership

Quality management

Audits & inspections

Problem solving

Communication skills

Project management

English proficiency

Educación

Master’s degree in Pharmacy, Chemistry, Life Sciences or related field

Descripción del empleo

Offer

• challenging position with broad responsibilities within pharmaceutical quality and compliance
• opportunity to contribute to quality improvements, product launches and international operations
• room for professional and personal development within a growing organization

Position

As Senior Quality Assurance Lead / QP & RP at Eurocept Pharmaceuticals, you will be responsible for maintaining and improving pharmaceutical quality and compliance. You work within a close-knit Quality team and report to the Director Quality & Compliance. In this position, you combine Quality Assurance leadership with responsibilities as QP and RP. You ensure that pharmaceutical products meet applicable GxP and regulatory requirements before market release.

You develop and improve the Quality Management System (QMS), including SOPs, deviations, CAPAs and change controls. Furthermore, you will coordinate internal and external audits, support regulatory inspections and manage supplier and customer qualifications. Also, you oversee quality agreements and investigate quality issues to identify root causes and implement sustainable improvements.

In addition, you will be responsible for batch certification, Product Quality Reviews (PQRs) and ongoing stability studies. You monitor out-of-specification results and oversee narcotics management, including regulatory reporting. You support new product launches and work closely with internal departments and international partners. Through training, guidance, and continuous improvement initiatives, you contribute to a strong quality culture. In short, a broad senior quality position combining operational responsibility, regulatory expertise and leadership.

Profile

• master’s degree in Pharmacy, Chemistry, Life Sciences or a related scientific discipline
• certified Qualified Person (QP), preferably with experience as Responsible Person (RP)
• at least 3 years of experience in pharmaceutical quality management, including leading quality initiatives and teams
• extensive knowledge of GMP, GxP regulations, pharmaceutical quality systems and regulatory compliance
• experience with QMS development, audits, inspections, CAPAs, change controls and risk assessments
• strong analytical, problem-solving, and decision-making skills, combined with a structured approach
• excellent leadership, communication, and project management skills, with a strong sense of business awareness
• proficient in English, both written and spoken

Organisation

Our client, Eurocept Pharmaceuticals, is a growing international pharmaceutical organization founded in 2001. Its headquarters are located in Ankeveen, with an additional logistics facility in Hilversum. The company operates internationally through local representatives and partnerships.

Depending on the product, Eurocept acts as marketing authorization holder, manufacturer, local representative, distributor, or wholesaler. Its activities include pharmaceutical registration, pharmacovigilance, manufacturing, marketing, sales, and distribution.

Quality, regulatory compliance and customer satisfaction are central to the organization. Eurocept continuously strives to meet the highest pharmaceutical standards while expanding its international activities. The Senior Quality Assurance Lead / QP & RP plays a significant role in supporting these ambitions and further strengthening the Quality department.

Tagged as: Life Sciences