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Executive Director Quality, (Primary Qualified Person)

Description

For our Quality organization within Organon Heist op den Berg we are currently hiring a:

Executive Director Quality, (Primary Qualified Person) at H eist op den Berg

Purpose of the role

In this role you will be responsible for providing overall leadership and direction for the Quality organization at the Heist site with a total of over 200 employees. You will direct all aspects of the quality function including in-process, release and stability testing for non-sterile and sterile finished products, quality oversight at the site and compliance with worldwide external regulatory and internal (Organon Quality Management System) requirements.

You will need to interface with all site functions and the global Quality organization, will be part of the Heist Site Leadership Team and report to the Associate Vice President Internal Manufacturing Quality.

Welcome to the team

The Quality department is responsible for control and release of products, testing of incoming raw materials/packaging materials, bulk and finished products and raw materials. In addition, Quality 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.

Main responsibilities

  • Manages and leads the Quality organization and assures adequate staffing and skills at the Quality department: Lab Team, CMO Quality, Athena Quality, Compliance Team, Quality Systems Team and IPT Quality Teams (4).
  • Leads and contributes to alignment of the Heist site to the global strategy of Organon and represents Quality Heist both internally and externally.
  • Directs all activities of Quality Operations for the independent control and release of Organon and 3rd party pharmaceuticals products.
  • Is responsible for assuring that all manufacturing activities are in compliance with the GMP Health authority regulations, regulatory filing and internal Organon guidelines and procedures.
  • Directs and sponsors continuous improvement initiatives in Quality and at the Heist site to identify capacity problems and productivity improvements. Manages the entire budget and headcount for the Heist Q department.
  • Responsible for all people management activities within Quality. Leads and supports the recruitment and retention of employees, the development and execution of training programs and the execution of all performance management activities.
  • Manages the quality function including interacting/developing relationships with regulatory agencies in Belgium as well as with EMA and other regulatory agencies.
  • Ensures that the products are flowing through the facility in a compliant and timely manner.
  • Sponsors a Safe by Choice, Target Zero safety culture in the organization

    • Your profile

  • Master's Degree in (Industrial) Pharmacy (or comparable).
  • EU Qualified Person or the ability to be registered as such in Belgium.
  • A minimum of 10 years' experience in the EU and/or FDA regulated pharmaceutical industry in various quality, manufacturing, or technological/analytical roles; extended experience in sterile/aseptic manufacturing.
  • 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
  • Growth opportunities within an international organization.
  • hospitalization insurance, meal vouchers and an interesting pension fund.
  • Paid vacation days.
  • Variable bonus system.
  • Company car.

    • Who We Are:

    Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

    As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. 

    If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at .

    Search Firm Representatives Please Read Carefully 
    Organon LLC, 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. 

    Annualized Salary Range

    Employee Status:

    Regular

    Relocation:

    Domestic/International

    VISA Sponsorship:

    Yes

    Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

    10%

    Flexible Work Arrangements:

    Work Week

    Shift:

    Not Indicated

    Valid Driving License:

    Yes

    Hazardous Material(s):

    Number of Openings:

    1

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    Executive Director Quality, (Primary Qualified Person)

    Company:
    organón
    City:
    Heist-op-den-Berg
    Contract type: 
    Permanent, Full-time
    Degree level: 
    Master
    Career level: 
    Director
    Published:
    23.06.2023
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