Director Quality Systems & Compliance

Job Description

We are looking for a strong leader with excellent attributes including an international and cross functional mindset, and the ability to maintain and develop strong working relationships with network leaders. You are looking for an opportunity to play an important role in taking (Quality) Compliance in a complex organization to the next level in terms of team-, system and process development.

For our animal health location in Boxmeer we are currently recruiting a Director Quality Systems & Compliance

Welcome to our team

The production facilities in Boxmeer and De Bilt are part of our global animal health production network and manufacture and package animal health products according to Good Manufacturing Practices standards (GMP). Our production organization consists of several Integrated Process Teams (IPTs) and Centers of Excellence (CoEs). Our Quality Assurance group (~150 employees) ensures every single material used inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our high standards of quality and meets all regulatory requirements.  Our Quality Systems & Compliance team (~45 employees) is responsible for maintenance and improvement of our Quality Systems for assuring compliance to cGMP (Good Manufacturing Practices) at the Boxmeer and De Bilt sites, and for surveillance of the quality of our products once released to the market, and for maintenance of our quality masterdata.

About the role

Reporting into our Site Quality Head, you will be responsible for managing and developing our Quality Systems & Compliance department with the purpose to ensure compliance according to the current European and international quality regulations and company guidelines at our manufacturing sites Boxmeer and De Bilt, enabling unconstraint and compliant supply of vaccines and pharmaceuticals according to global and local legislations. You work in close collaboration with a wide variety of leaders in our organization (Manufacturing, Global Quality, Quality Assurance, Quality Control and Regulatory Affairs).

Main tasks and responsibilities

• Leading the Quality Systems & Compliance department (~45 employees, 4 direct reports), ensuring the development of an effective, focused and strong team by understanding: their abilities and unique contribution to broaden their skill set to be agile and prepared for any future business requirements.
• Supporting and motivating the team to improve our Quality Management System processes.
• Managing divisional audits and Health Authority inspections, including Corrective And Preventive Actions (CAPA) planning and implementation.
• Ensuring proper internal escalation and heath authority communication in case of significant deviations.
• Supporting other directors in Manufacturing and Quality to ensure alignment with the European and International quality regulations/requirements.
• Initiating, managing, and contributing to the development of improvement business cases and the implementation of improvement initiatives (efficiency and or effectiveness) including benchmarking with other sites.
• Managing the master data systems, which involves different areas in the company.
• Translating the yearly Global Quality and Operations strategy into departmental plans and actions.
• Ensuring the current regulations are fully implemented and, if not, a list of GAPs and action plan is created and implemented.
• Supporting new projects regarding legislations from different countries.
• Ensuring the Quality Systems team will be involved and supporting digitalization implementation programs.

Your profile

• Academic degree in a relevant field (Pharmacy, Medical Biology, (Bio)Chemistry, (Bio)Process Technology, or related scientific fields) combined with at least 7-10 years of relevant experience in an international pharmaceutical company
• Proven track record of managing and developing large organizations and leading other managers in a complex and relevant organization;
• Strong knowledge of international Quality Directives (EudraLex) and GMP standards;
• Experience working with health authorities and managing audits and inspections;
• Excellent command of the English language, oral and written.

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;
• 25 days of leave;
• Company car or car allowance;
• Solid Pension Plan;
• Bonus Plan subject to the company annual results;
• Long Term Incentive Plan;
• Flexible working arrangements.

Animal Health

Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet.

Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

For questions about this vacancy

Please send an email including the vacancy number and job title to the following email address: 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:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

02/1/2025

*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: R323127