Associate Director QA QMS Job

Date: Jan 24, 2019

Location: Haarlem, NH, NL

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Requisition ID: QUA008230

Are you experienced in implementation of Quality Management Systems? Are you ready for your next challenge and do you want to be part of a global healthcare leader? We would like to meet you!

We have an exciting opportunity for an Associate Director QA QMS at our MSD site in Haarlem.

Purpose of the role
In this key role you will lead and oversee implementation and maintenance of the site’s Quality Management System (QMS). This is a key role in inspection readiness of the site. You will need to ensure compliance with QMS requirements and procedures. And you will be responsible for oversight and activities related to quality risk management, change management, qualification and validation and GMP/GDP relevant training.

Welcome in our team
The Quality Operations department (150 employees) is responsible for control and release of products, testing of incoming packaging materials, products and raw materials. In addition, Quality Operations maintains regulatory compliance of the final product to markets all over the world and is responsible for maintaining the quality management systems in accordance with worldwide pharmaceutical legislation, regulations and the company corporate policies.

Haarlem is MSD's most flexible packaging site for medicines and vaccines to more than 140 countries worldwide. Future growth of the Haarlem site is upcoming with the increasing market demand. Brexit will potentially add additional control and release activities to the site. International packaging for MSD’s own production sites and CMO’s is centralized in Haarlem, resulting in an expansion of the Quality organization and its QC labs.

Main responsibilities:
  • Responsible to manage and oversee the site’s Quality Management System (QMS). 
  • Responsible for all people management activities for 15 direct reports. Contribute to the recruitment and retaining of employees, the development and execution of training programmes and the execution of all performance management activities.
  • Ensure a documentation management system is in place which is compliant with company requirements
  • Ensure that there is a change management system to assess the impact of changes on a product, validated processes, test methods, specifications, regulatory filings and GMP documents
  • Review and approve Validation Master Plans and documentation for qualification and validation activities
  • Ensuring an adequate training system is in place for all personnel engaged in GMP activities
  • Ensure that Quality Risk Management (QRM) processes and procedures are implemented and executed 
  • Responsible to monitor the health of the site’s QMS and to ensure that opportunities for continuous improvement are identified, implemented and their effectiveness monitored. 
Qualifications

Your profile
  • Master's Degree in Pharmacy, Life Sciences, Engineering 
  • A minimum of 8 eight years' experience in the FDA and/or EU regulated pharmaceutical environment, preferably in a manufacturing site in quality and/or manufacturing roles. 
  • Demonstrated in-depth knowledge of global health authority regulations and quality and compliance requirements with the ability to effectively communicate these requirements. 
  • Registered as Qualified Person is preferred 
  • Demonstrated leadership and change management skills with a continuous improvement focus
  • Fluency in English and Dutch
  • Knowledge of and experience in applying Six Sigma and Lean methodologies
  • Able to make and act on decisions while balancing speed, quality and risk. You will need to have the ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives. 

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;
  • MSD Incentive Plan;
  • Travel allowance for commuting;
  • Numerous training, coaching and e-learning modules for long term job opportunities and development.

About us

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.

Acquisition by agencies is not appreciated. 

#LI-DNI


Job: Qual Assurance & Ops Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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