Executive Director Quality Operations
MSD
Haarlem, NH, NL
8 dagen geleden

QUA008771

Are you experienced in the FDA and / or EU regulated pharmaceutical environment and do you have demonstrated experience in leading and directing larger quality / operational units in a pharmaceutical manufacturing company?

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 Executive Director Quality Operations at our MSD site in Haarlem.

Purpose of the role

In this role you will be responsible for providing overall leadership and direction for Quality Operations at the Haarlem site with a total of 150 employees.

You will direct all aspects of the quality function including process and release testing for non-sterile and sterile finished products, quality oversight at the site and compliance with worldwide external and internal regulatory requirements.

You will need to interface with all site functions and the global Quality organization, will be part of the MSD Haarlem Site Leadership Team and report to the Associate Vice President Global Pharmaceutical Operations EMEA.

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 and is resulting in an expansion of the Quality organization and its QC labs.

Main responsibilities :

  • Manage and lead Quality Operations and assures adequate staffing and skills at the department.
  • Lead and contribute to alignment of Manufacturing and Quality Operations Haarlem to the global strategy of MSD and represents Quality Operations Haarlem both internally and externally.
  • Direct all activities of Quality Operations for the independent control and release of MSD products both pharmaceuticals and vaccines.
  • Responsible for assuring that all manufacturing activities are in compliance with the GMP Health authority regulations, regulatory filing and internal MSD guidelines and procedures.
  • Direct and sponsor continuous improvement initiatives at Quality Operations and the Haarlem site to identify capacity problems and productivity improvements.
  • Responsible for all people management activities within Quality Operations. Lead and support the recruitment and retaining of employees, the development and execution of training programs and the execution of all performance management activities.
  • Manage the quality function including interacting / developing relationships with regulatory agencies in the Netherlands as well as EMA and the FDA.
  • Your profile

  • Master's Degree in Pharmacy, (Bio-)Chemistry, Life Sciences or equivalent
  • A minimum of 10 years' experience in the FDA and / or EU regulated pharmaceutical industry in various quality, manufacturing or technological / analytical roles.
  • Demonstrated leadership to larger organizational units ( manager of managers ) with a focus on coaching and people development / change management skills.
  • Knowledge of and experience in business and financial processes and in continuous improvement of these processes e.g. Six Sigma and Lean tools and methodologies.
  • Strategic planning, leadership and organizational skills and capabilities.
  • 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.

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