Senior Specialist QA (Deputy QRP)

Job Description

For our EMEA Supply Chain Hub Quality team in Haarlem, the Netherlands, we are looking for a Deputy of the Quality Responsible Person who is passionate about quality, supply chain planning and distribution, as well as trading of pharmaceuticals. In addition to the required education and experience in GDP/GMP, the candidate should bring a good team spirit, motivation, and the will to succeed.

Welcome to the team

The EMEA SC Hub is an organization focused on the core supply chain functions of planning, demand fulfilment and logistics in Europe, Middle East, and Africa. It operates under licenses issued by the local Health Authority for the performed trading activities, supported by other company functions, such as External Manufacturing, Auditing, Procurement and Finance.  This SC organization is a crucial node in the middle of the supply chain with broad visibility end-to-end, ensuring that the import, export, and trade activities are executed under full source - and destination control for the traded pharmaceuticals. As the EMEA SC Hub is based both in the Netherlands (Haarlem) and in Switzerland (Lucerne), you will be working together with the Dutch QRP and with the Swiss QRP on the EMEA SC Hub Quality Management System to ensure compliance with all applicable national and international regulations as well as with our company’s policies.

Purpose of the position

In this role you will act as Deputy of the Quality Responsible Person (QRP) to the Trading Entities in scope of the QRP responsibilities, in accordance with the Dutch law on Medicinal Products, and support the QRP in all activities related to the maintenance of the EMEA SC Hub Quality Management System and the trading licenses. As Deputy QRP, you will play a key role by building strong partnerships and collaborations at all levels, locally, regionally, and cross-functionally to ensure clear definition of requirements and compliance to the respective trading licenses.

Our international EMEA SC Quality team located in Haarlem and Lucerne is a diverse team of motivated Quality professionals with broad knowledge and experience, having fun working together and learning from each other in the process.

Primary responsibilities:

• Act as Deputy of the QRP to the Dutch Trading Entities in scope of the QRP responsibilities, in accordance with the Dutch law on Medicinal Products. Support the QRP in all activities and deputize during the QRP’s absence.

• Support the maintenance of the EMEA SC Hub Quality Management System in accordance with GMP, GDP, Dutch law, Swiss law and our company’s policies.

• Execute the assigned activities in scope of the EMEA SC Hub QMS, according to requirements and within deadlines (e.g.: write procedures, provide trainings, perform internal audits, recall execution, etc.).

• Ensure that the medicinal products are imported, exported, wholesaled, and traded abroad by the Trading Entities in accordance with GDP requirements and in compliance with the relevant national and international regulations and guidelines.

• Participate in the quality oversight of activities such as auditing, review and approval of changes, significant deviations and associated CAPAs of the relevant third-party logistics providers and transportation companies.

• Review and approve Quality Agreements involving the Dutch Trading Entities.

• Support local Health Authority Inspections and Internal Audits for the entities in scope, including preparation and coordination.

Your profile:

• Demonstrated professional training and experience in the GDP/GMP regulated fields.

• Master's or higher degree in Pharmacy, Chemistry, Biology, or equivalent.

• Minimum of 3 years' experience in the pharmaceutical industry, with solid quality and compliance experience.

• Previous experience as QRP or QRP Deputy is preferred.

• Experience in a GDP/GMP environment involving physical distribution of medicinal products.

• Fluency in English and preferably also Dutch, additional European languages are a plus.

• Very good computer literacy (Microsoft Outlook, Word, Excel, PowerPoint).

• A self-starter, demonstrating accountability for your own output and a strong sense of ownership for your projects, as well as the ability to define and manage multiple priorities.

• Strong interpersonal, communication (both verbally and in writing), collaborative and leadership skills in dealing with a broad variety of cultures to communicate, collaborate and influence.

• User know-how of SAP/ERP systems, TrackWise, any Quality Document Management Systems is prefered.

• Independent, very well-structured and solution-oriented approach to work with clear focus on organizational objectives.

• Ability to motivate and influence others, also outside of hierarchical structures.

What we offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

• Competitive salary.

• Annual Incentive Plan (AIP).

• Competitive Pension Plan.

• 25 days of leave.

• Attractive collective health care insurance package with considerable reduction rates.

• Senior Leadership Development Program for long term Career development.

• Numerous training, coaching and e-learning modules for long term job opportunities and development.

Heb je vragen over deze vacature? Stuur je vraag inclusief het vacaturenummer en de vacaturetitel naar het volgende emailadres: RecruitmentNL@MSD.com .

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

04/30/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R341374