Job Description

For our Distribution & Supply Chain Quality team we are currently recruiting for the role of Senior Specialist QA / GDP

Purpose of the role

In the role of Senior Specialist QA/GDP you will manage the collaboration and relation with our regional Third Party Logistic Service Providers (3PLs), located in Belgium. You will be part of an international team, which consists of 4 colleagues and you will report into the Associate Director Quality Assurance – SC Hub Quality Team Lead.

Main responsibilities

Lead & Coordinate as the primary Quality oversight of the regional 3PL which includes:

• Maintain Quality oversight and management of 3PL distribution complaints, change control, deviations and audits, including trending and continuous improvement initiatives;
• Serve as primary quality point of contact, internally for 3PL inbound & outbound shipments and externally for 3PLs;
• Set up and maintain GDP Quality systems related to the importation, storage, warehousing, and distribution activities delegated to the 3PL and ensure overall compliance to GDP and Company policies;
• Support with 3PL Transportation Lane Risk Assessment;
• Collaboration with internal and external stakeholders to continuously improve Logistics providers, transportation lanes' performance by periodically reviewing and addressing internal and external KPIs, CAPA effectiveness, and audit findings.

Support with Quality Management of SC Hub:

• Support with standardization and implementation of SC Hub QMS as driven by global initiatives;
• Support with the management of deviations, CAPAs and change control systems, competent authority inspections and quality metrics reporting, at the SC Hub;
• Support the SC Hub Annual Internal Audit Schedule by leading self-inspections and reviewing self-inspection protocols and reports of team Lead Auditors;
• Act as Back-up in SC Hub team;
• Support with trainings and guidance in GDP elements and procedures, creating awareness and ensuring compliance with regulatory requirements and local procedures, including the Falsified Medicines Directive (EU 2016/161).

Your profile

• Bachelor’s degree in Pharmacy, Chemistry, (Micro-) Biology, Chemical Engineering or Supply Chain Management;
• Minimally 3 years of expertise and broad experience in Quality Systems, Quality Assurance, and Quality Control, including solid knowledge of global GDP/GMP, regulatory requirements, and good documentation practices;
• Excellent problem-solving skills, based on science, facts, data, and understanding of the regulatory requirements in complex and evolving environments;
• Strong demonstrated interpersonal, communication and able to handle organizational complexity and ambiguity;
• You have good people/team collaboration experience;
• You are fluent in English (must) and you have a good command of Dutch (preferred).

We offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our compensation and benefits package is very competitive.

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.

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

Search Firm Representatives Please Read Carefully
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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:

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:

Requisition ID:R523461