Associate Director Quality Assurance

Job Description

We are looking for an Associate Director Quality Assurance to join our team in Boxmeer.

Exciting Opportunity: Associate Director Quality Assurance (International Seed Management, ISM) Are you ready to take on a challenging global SME role that offers considerable independence and the chance to make a significant impact? You will work closely with different departments (R&D, Process development, Registration, Production) and organizational leaders, managing a diverse and pivotal portfolio focused on viral safety, quality of our seeds and cells used to make our vaccines and biologicals within the company.

Welcome in our team

The International Seed Management group (7 employees) is part of the global Bioprocess Technology Solutions (BTS) team (~230 employees) that drives and executes Bioprocess technology excellence in close alignment with their partners in Research & Department (R&D) and Manufacturing in order to ensure robust product introductions, product transfers and a reliable product supply to customers.  BTS has considerable expertise in viral cell culture, bacterial fermentation, downstream processing, purification, freeze drying and vaccine formulation.  The ISM group is responsible for managing and support of the global production, testing, documentation and storage of Master seeds, Working seeds and first Production seeds and production cells to enable continuous production and timely product registration of vaccines and biologics within Animal Health.

Your job

International Seed Management (ISM) has a global accountability to assure quality and storage of seeds within MSA AH. Within the ISM group there is a position for an Associate Director Quality Assurance responsible for the management, quality testing and storage of Seeds (MS, WS, PS), execution of risk assessments for extraneous agents testing within our Global Animal Health organization. Furthermore, to support and work on improving procedures together with the R&D and Manufacturing groups to ensure production, testing and storage of high quality and compliant Seeds and continued product supply.

Your responsibilities

• Technical and operational lead and SME of the R&D/extraneous agents pillar within the ISM-team.
• Regulatory knowledge about global seed testing requirements
• Experienced Subject Matter Expert (SME) for R&D partners for Seed-related issues on a global scale.
• Management of extraneous agents, including technical and operational input, engagement with external partners (CRO, CDMO) including the oversight of delivery and performance.
• Global coordination of extraneous agents testing activities between R&D, Regulatory affairs and BTS.
• When needed, act as ISM lead for the ISM department (as back-up to ISM lead)
• Development of global strategy for extraneous agents’ management.
• Leading risk assessments and providing technical support for these risk assessments.
• Oversight of additional testing risk assessments for established Seeds.
• Development of novel, innovative approach to risk assessments in response to changing regulatory requirements.
• Manage project using connectivity planning tool.
• Outsourcing and managing projects for development of novel testing technologies.
• Preparation Master Seed protocols.
• Set priorities together with the ISM team.
• Development and maintain business relationship with test providers.

Your profile

• MSc or PhD in biotechnology / process engineering / virology or related fields
• 10+ years of experience in working in a science & technology orientated team in a complex (Bio)pharmaceutical environment.
• Proven track record of managing multidisciplinary project portfolios in the areas of process development / viral safety testing / seed management / communication/ working with interdisciplinary teams.
• Experience in viral seed and cell line testing strategies is a pre
• Experience with interacting on a global level;
• Strong analytical and problem-solving skills, and the ability to work independently and make decisions in a constantly changing environment;
• Understanding of global regulatory/compliance requirements for seeds;
• Excellent communication skills in English

What we offer

Being an Associate Director at our company means you will work together with a team on animal healthcare in an international environment. You will get the opportunity to develop yourself.
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 Division

Our Animal Health division is a trusted global leader in veterinary medicine, dedicated to the health and well-being of animals. 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. We offer one of our industry’s most innovative portfolio of products, services and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species.

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:

03/27/2025

*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: R325279