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Vacancy: Senior Quality Systems Specialist, Vollenhovermeer, Oss, Netherlands

Vacancy: Senior Quality Systems Specialist, Vollenhovermeer, Oss, Netherlands
Posted on: Aug.13.2021

About Us

We are one company, but we operate under two different corporate brand names.
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States, Canada & Puerto Rico. We are known as MSD everywhere else.

Purpose of the role

The Senior Quality Systems specialist is responsible for the overall implementation and continuous improvement of our company’s Quality Management System on site and the Site Compliance Plan throughout their knowledge and areas of expertise.

The main areas of expertise are in internal and external inspection and auditing, Quality Risk management, Quality Systems management including general Quality and cGMP Compliance oversight, regulatory affairs and authority liaison function as well as other general specified tasks (e.g. Site Master File, Manufacturing License, Site Accreditations).

Welcome in our team

Quality Operations Biotech (around 60 people) is responsible for ensuring that our Manufacturing Division Oss manufactures, tests and releases Biological Drug Substances and Bulk Drug Products in accordance to applicable local and international regulations. To this end the various Quality departments actively collaborate and set standards for all other Integrated Process Teams (IPTs) and CoEs (Center of Excellences) of our Manufacturing Division Oss as well as regularly interact with other Manufacturing Division sites. This position is for the Quality Systems team within the Quality Operations organization.

Main tasks

-Supporting all internal verification and system/process audit activities which are in line with relevant quality procedures, guidelines and directives to ensure Permanent Inspection Readiness and to monitor the status of GMP level, status and action steps or other relevant performance indicators.
-Providing advice/guidance to the functional areas on quality knowledge, procedures, guidelines and directives.
-Execution of all necessary means with regard to preparations, execution and follow-up on inspections at our company.
-Execution of all necessary means with regard to Inspection relevant documents (Manufacturing License, GMP Certificate, Site Master File, Authority Accreditations).
-Supporting continuous improvement initiatives and the use of our company’s Quality Risk Management methodologies and tools.
-Supporting and monitoring decision-making and enable CoE/IPT-members to retain and increase the required/desired level of expertise on Quality and cGMP Compliance topics.
-Facilitating Quality System oversight (e.g. Site Quality council, Chapter Owner meeting, Site Quality Risk Management committee).
-Providing day to day support for Biotech, raising concerns if needed or directing users to do so. Partner with relevant internal and global groups (e.g. our company, FDA, EMEA) for building, maintaining and sharing knowledge and information.
-Active contribution to realization of corporate policy on safety, health and environment. Demonstrate personal commitment with respect to working safely, healthy and environmentally friendly.
-Oversight of all main team activities and represents the team in case of absence of Team Leader. Able to act as the right hand of Team Leader.

Your profile

-At minimum a bachelor’s degree (Dutch: HBO/ HLO), preferable in Science or comparable work experience.
-At least 7 years of relevant experience in the pharmaceutical industry and cGMP.
-Extended knowledge of Quality and Compliance guidelines, Quality Management Systems, Quality Risk Management principles.
-A flawless quality mindset and able to convert this mindset into practice and with strong leadership skills to bring others on the same page.
-Excellent interpersonal and communication skills, verbally and written (Dutch and English).
-Has the leadership competencies to successfully represent our company to authorities and other our company sites and global groups.
-Ability to work independently as well as in teams.
-Effective planning and structured working skills.
-Strong focus on clients and end-user.

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 and a 3% year-end bonus;
-35,5 days of leave;
-Attractive collective health care insurance package with considerable reduction rates;
-Solid Pension Plan;
-Incentive Plan;
-Travel allowance for commuting;
-Numerous training, coaching and e-learning modules for long term job opportunities and development.


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