Project Quality Lead

Job Description

New role covering all Quality perspectives in a significant capital and transfer project in Boxmeer.

For our Animal Health location Boxmeer, we are currently recruiting a Project Quality Lead

Welcome to our team

Our production facilities in Boxmeer are part of our global animal health production network and manufacture and package animal health products according to Good Manufacturing Practice standards (GMP). Currently, we are planning to expand our organization’s production capacity to produce our latest scientific innovation in animal health, by investing in a new powder filling line in Boxmeer. Once fully operational, this new IPT could consist of approximately 80 – 100 FTE. To ensure compliance to FDA standards, we are looking for a Project Quality Lead.

Purpose of the role

Reporting into the Executive Director Global Quality Small Molecules, your first responsibility involves building and managing a team of Quality experts to cover all aspects of the project from a Quality perspective. You lead the Quality workstream and take on the responsibility of driving GMP decisions and ensuring FDA compliance for this significant capital and transfer project, overseeing the full project life cycle. As a key member of the project team, working cross-functionally with all stakeholders you ensure that all activities are conducted in adherence to GMP standards, and to prepare the new building to operate in full GMP compliance.

Tasks and responsibilities are, but not limited to

• Help to select the best compliance options for equipment and facilities design; make sure compliance aspects are visible, understood and considered by participating on project workshops and discussions or consulting any Quality experts whenever needed.
• Organize all Quality reviews of capital project documents (URS, Design Plan, IQ, OQ, PQ).
• Ensure all Quality activities are executed according to plan.

• Support Science & Technology in all transfer activities from a compliance perspective.
• Organize the QC testing and QA release of the validation batches.
• Design and prepare Quality activities in term of processes, human resources and equipment.
• Translate FDA and EU GMP requirements into the project activities as well as the routine production.
• Define GMP activities processes with the cross functional workstream and organize the built of the relevant systems (IT systems, SOPs).
• Build strategy for Quality activities related to QC testing and QA release, establish contractor management, organize on-site Quality activities.
• Support other department to develop compliant systems for operations, warehousing and maintenance and engineering.
• Develop inspection readiness program all long the project phase.

Your profile

• Degree in Science, Process Technology, Engineering or equivalent qualifications.
• Senior-level and broad Quality experience gaining expertise in FDA GMP-certified pharmaceutical manufacturing.
• Proven track record in effectively leading and developing teams.
• Successful experience in a complex international environment with matrix organization.
• Fluent in the English language, both spoken and written.

What we offer

A new position with high visibility offering the opportunity to contribute to shaping our future through leadership on this ambitious and pivotal capital project. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

• Competitive salary.

• 25 days of leave.
• Company car.
• Bonus Plan subject to the company annual results.
• Incentive Plan.
• Solid Pension Plan.

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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

10/18/2024

*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.

Job Posting End Date: 10/18/2024

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: R313912