Team Lead Product Surveillance

Job Description

For our location Boxmeer we are currently recruiting a Team Lead Product Surveillance

Welcome to our team

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. As part of our site Quality department, the QA Systems and Compliance team (~50 employees, divided over 4 smaller teams) is responsible for maintenance and improvement of the Quality Systems, and for assuring compliance to cGMP (Good Manufacturing Practices) at the Boxmeer and de Bilt sites, for maintenance of our quality master data and quality surveillance of our products once released to the market. The team responsible for Product Surveillance consists of 11 employees.

About the role

Reporting directly to the Director of Quality Systems & Compliance, your primary objective is to provide daily direction, coaching, and priority-setting within the Product Surveillance team. You will play a pivotal role in both establishing and executing the strategic vision for the department. This position demands a strong emphasis on developing and maintaining stable, efficient workflows and fostering effective teamwork. You will lead improvement projects focused on technical enhancements, quality assurance, and safety, utilizing Lean Six Sigma methodologies to drive excellence. Additionally, you will cultivate a culture of collaboration within the team and across supporting teams within the organization. This role requires close cooperation with mainly Quality Assurance (QA), Quality Control (QC), and Bioprocess Technology Solutions (BTS) to ensure alignment and enhance operational effectiveness.

Main tasks

• Lead, coach, and support the Product Surveillance team to foster a high-performing work environment.
• Oversee and optimize existing run-and-maintain processes within QA Product Surveillance. Drive efficiency and compliance through standardization and continuous improvement initiatives, collaborating with Site Support Organizations (SSOs), other sites, and global departments to ensure the timely execution of key tasks.
• Convert theoretical GMP frameworks—such as guidelines and core documents—into practical best practices that enhance operational effectiveness.
• Assist departments in the standardized implementation of the overall Quality Strategy, ensuring alignment with organizational goals.
• Oversee the Stability Study Program, including the development of stability protocols, study management, stability profile evaluations, and reporting.
• Manage the investigation process for both initial and confirmed Out of Specification (OOS) results in stability studies.
• Monitor the implementation of Corrective Action and Preventive Action (CAPA) initiatives related to stability issues, ensuring effective resolution.
• Lead the Product Quality Review process, which encompasses the assessment of Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs), as well as process and method capability analyses.
• Oversee the Product Quality Complaints process, ensuring timely resolution and effective communication.
• Address and resolve frequent product-related complaints, actively working to mitigate any impact on product quality.

Your profile

• Bachelor’s or master’s degree in a relevant field ((Bio)Chemistry, (Bio)Process Technology, or related scientific fields).
• Relevant experience in a pharmaceutical manufacturing organization gaining knowledge of cGMP regulations and expectations governing facilities, equipment and procedures for the manufacture of (bio)pharmaceutical products.
• Strong leadership and management abilities, with experience in coaching and developing a high-performing team.
• Familiarity with Lean Six Sigma or other process improvement methodologies, with a proven track record in leading improvement projects.
• Excellent command of the Dutch and English language.
• Living at a reasonable distance from Boxmeer.

What we offer

We offer the opportunity to guide our team in exploring new ways to improve productivity and efficiency. By fostering a collaborative environment and encouraging innovative thinking, you will play a key role in developing a self-sustaining team dedicated to continuous improvement and quality excellence. 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 allowance.
• 35,5 days of leave.
• Attractive collective health care insurance package with considerable reduction rates.
• Solid Pension Plan.
• Annual bonus based on own and company performance.
• Travel allowance for commuting.
• Numerous trainings, coaching and e-learning modules for long term job opportunities and development.

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.

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:

03/26/2025

*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: R336884