Senior Specialist, Quality Responsible Person, Supply Chain Hub (Netherlands)

Job Description

Permanent contract is possible

Senior Specialist, Quality Responsible Person, Supply Chain Hub (Netherlands)

This hybrid role is primarily based in Amsterdam (The Netherlands)

Purpose of the role

Act as the Quality Responsible Person/Designated Person in line with EU Guidelines on Good Distribution Practice (GDP) for medicinal products for human use (2013/C 343/01), GDP for active substances, the European Medical Device Regulation ((EU) 2017/745), and other relevant guidelines and regulations. Provide quality oversight to the regional distribution center.

Main responsibilities

• Oversee GDP quality systems related to the importation, storage, warehousing, and distribution activities delegated to the 3PL, ensuring overall compliance with GDP and company policies.
• Manage quality agreements and documentation with all suppliers, including 3PL, to support day to day operations such as logistics and distribution complaints, change control, and deviations, including trending and continuous improvement initiatives.
• Enter and close events in the global system for Distribution Event Management.
• Collaborate with internal and external stakeholders to continuously improve the performance of logistics providers and transportation lanes by periodically reviewing and addressing internal and external KPIs, CAPA effectiveness, and audit findings.

Your profile

• Bachelor’s degree or higher in Pharmacy, Chemistry, (Micro-)Biology, or Chemical Engineering (or equivalent).
• Minimum of 5 years of experience in the pharmaceutical industry.
• Preferred experience as a Quality Responsible Person.
• Extensive expertise in Quality Systems and Quality Assurance.
• In-depth understanding of global GMP/GDP standards.
• Strong communication skills for interacting with Health Authorities.
• Hands-on experience managing Health Authority inspections.
• Proficiency in applying pharmaceutical Quality Systems.
• Solid grasp of EU cGMP, GDP, ICH, and local regulations.
• Ability to interpret and implement quality guidelines effectively.
• Experience in Quality Risk Management.
• Project management skills.
• Computer literacy, including proficiency in MS Office.
• Familiarity with supply chain operations.
• Knowledge of ERP systems, SAP, and Track Wise.
• Fluency in both Dutch and English.

What we offer

We welcome you to a truly global, dynamic, and challenging environment with excellent personal development opportunities. 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 allowance.
• 35,5 days of annual leave.
• Attractive collective health care insurance package with considerable reduction rates.
• Solid Pension Plan.
• Annual bonus based on own and company performance.
• Travel allowance for commuting.
• Numerous training, coaching, and e-learning modules for long term job opportunities and development.

Are you the quality-focused professional we're looking for? If you are willing to learn or meet these requirements and are passionate about maintaining the highest standards in pharmaceutical industry, we'd love to hear from you!

Secondary Job Description

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.

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

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

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

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R530396