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MSD Associate Director Quality & Qualified Person QP Netherlands, North Holland 396670788
Job Description
Purpose of the position
In this crucial role, you'll directly support the Director, GDQ (Global Development Quality), by ensuring the smooth operation of our global clinical supply chain. You'll achieve this by overseeing all activities related to the disposition of clinical finished goods used in our worldwide trials. This includes building a dedicated team of two Senior QA Specialists at our Haarlem site.
Your primary focus will be ensuring the quality and compliance of investigational medicinal products (IMPs) throughout our Global Clinical Supply (GCS) Warehouse and Distribution network. You'll achieve this by overseeing all quality assurance activities related to Good Manufacturing Practice (GMP) compliance for the IMP license. Additionally, you'll design and manage a robust Quality Management System (QMS) for the clinical supply warehouse and distribution functions.
To maintain a seamless global clinical supply chain, you'll manage the distribution, and final disposition of clinical finished goods. This collaborative role will require you to work closely with internal and external partners to guarantee the on-time delivery of cGMP-compliant clinical supplies worldwide. You'll also be the company's voice during regulatory inspections pertaining to the IMP license and QMS.
The Global Development Quality (GDQ) organization is responsible for providing quality oversight of internal clinical packaging and distribution operations and supply chain management support for the end-to-end clinical supply chain.
Primary responsibilities
Act as Quality site lead / QP for quality aspects of warehousing and distribution activities at the site in Haarlem.
Provide QP certification of batches of IMPs packaged for Clinical Trial use as required by directive 2001/20/EC.
Drive the implementation of the quality strategy at site.
Oversee the recruitment, management and development of the Quality team.
Lead the departmental and site preparation for internal and external audits
Champion the continuous improvement of the quality strategy by prioritizing, initiating and monitoring related improvements.
Legally responsible for the executions of releases and the execution of potential recalls.
Your profile
Master's degree in science or Pharmacy qualification (QP eligible).
6-8 years in pharma Quality Assurance, ideally with manufacturing & logistics experience.
Several years of experience as a Qualified Person (QP).
Strong team leadership & coaching skills.
Proven ability to analyze, recommend & lead quality initiatives.
Excellent communication with strong analytical thinking and EU GMP/cGMP knowledge.
Fluency in English (written & spoken)
Travel willingness (up to 10%)
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;
35,5 days of leave;
Attractive collective health care insurance package with considerable reduction rates;
Solid Pension Plan;
Incentive Plan;
Travel allowance for commuting;
On-site sports facilities
Numerous training, coaching and e-learning modules for long term job opportunities and development
Current Contingent Workers apply
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