Director QA Compliance Job

Date: Feb 21, 2019

Location: Haarlem, NH, NL

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Requisition ID: QUA008224

Are you experienced in the FDA and/or EU regulated pharmaceutical environment and do you have demonstrated in-depth knowledge of global health authority regulations and quality and compliance requirements? 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 a Director QA Compliance at our MSD site in Haarlem.

 

Purpose of the role

In this strategic role you will be responsible for providing overall leadership and direction for the Quality function to the site with your team consisting of 15 employees.  You will need to ensure sustainable compliance of site processes, procedures and systems with the global company requirements and regulatory requirements and expectations.

 

You will need to interface with all site functions and the global Quality organization and you will be responsible for oversight and activities related to the management of regulatory inspections, the site auditing program, significant investigations and recall execution, CAPA management, regulatory compliance, complaints management, site quality agreements and data integrity compliance.

 

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:



  • Lead the site wide Permanent Inspection Readiness (PIR) program, influencing all IPT's (Integrated Process Team) and CoE's (Centre of Excellence) at the site. Report to Site Leadership Team on necessary GMP improvement programs for the site to remain permanent inspection ready.


  • Make independent decisions on the implementation of the quality management system (QMS) at the site.                      


  • 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.


  • Responsible for all people management activities for direct reports. Contribute to the recruitment and retaining of employees, the development and execution of training programs and the execution of all performance management activities.                     


  • Managing the quality function including interacting/developing relationships with regulatory agencies in the Netherlands as well as EMA and the FDA.
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.


  • Registration as Qualified Person is preferred     


  • Demonstrated in-depth knowledge of global health authority regulations and quality and compliance requirements with the ability to effectively communicate these requirement


  • 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

 

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;


  • 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. 


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


Job Segment: Compliance, Manager, Law, Engineer, CAPA, Legal, Management, Engineering

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