Associate Director Quality

Calling all passionate quality leaders Join us as Associate Director & Qualified Person and make a significant impact on the success of our global clinical supply chain 

This pivotal role lets you build and lead a team, ensuring the flawless delivery of life-changing medicines worldwide. 

Join us and make a real difference in patient lives.

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.

Welcome to our team

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.

Our team partners broadly across our company and our external partners to deliver continuous current good manufacturing practices (cGMP)-compliant clinical supply on time, every time, across the globe.

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;

Incentive Plan;

Travel allowance for commuting;

On-site sports facilities

Numerous training, coaching and e-learning modules for long term job opportunities and development

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:

Job Description

Calling all passionate quality leaders Join us as Associate Director & Qualified Person and make a significant impact on the success of our global clinical supply chain 

This pivotal role lets you build and lead a team, ensuring the flawless delivery of life-changing medicines worldwide. 

Join us and make a real difference in patient lives.

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.

Welcome to our team

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.

Our team partners broadly across our company and our external partners to deliver continuous current good manufacturing practices (cGMP)-compliant clinical supply on time, every time, across the globe.

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 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date: 06/13/2024

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: R283031