Associate Director Quality Assurance

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

• A competitive salary.
• Annual incentive plan.
• 35,5 days of leave.
• Attractive collective health care insurance package with considerable reduction rates.
• Solid Pension Plan.
• Travel allowance for commuting.

If you have questions regarding this opportunity?

Please send your question including vacancy title and number to: RecruitmentNL@MSD.com

About Us

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