Quality Responsible Person (QRP) - In-Market Quality - Belgium & Luxembourg

Job Description

For Organon Belgium & Luxembourg organization in Brussels we are currently hiring a:

Quality Responsible Person (QRP) – In-Market Quality

The position

In this Senior Specialist position, you will act as GDP (Global Distribution Practice) Responsible Person according to local legislation (Royal Decree 14/12/2006, article 90, paragraph 1, point 2 related to wholesale distribution). This includes the authority to act and take decisions to fulfill Health Authority (HA) requirements and to safeguard patient health. This position will be based in Brussels. You will report to the In-Market Quality Lead Switzerland, Belgium and Luxembourg.

The position offers partial remote work flexibility, with limited travel requirements.

Welcome to our team

The In-Market Quality Team consists of the manager and two Senior In-Market Quality Specialists, one based in Switzerland and one in Belgium.

Responsibilities

• Ensure regulations pertaining to Quality and Compliance for importation, distribution and wholesaling of the products on the market are fulfilled
• Where applicable, ensure adherence to Global Quality Manual.
• Health Authority (HA) interactions and notifications regarding Quality and Supply issues.
• Information and interaction with local business and regional Quality Management.
• Oversight of local vendors (e.g. 3PL).
• Ensure Quality perspective is brought into local business initiatives with Quality impact.
• Local coordination and execution of recalls.
• Primary country contact for Global Quality.
• Primary country contact for Health Authorities issues pertaining to Quality and Supply issues.
• Contact person for Quality/ Technical Agreements defining GXP responsibilities.

The QRP will be also responsible for:

• Maintenance of the local Quality Management System.
• Ensure changes are managed according to applicable procedures
• focusing on the management of authorized activities and the accuracy and quality of records.
• Ensuring that initial and continuous training programs are implemented and maintained.
• Ensuring that relevant customer complaints are handled effectively.
• Deviation Management.
• Preparation, review and approval of MAH (Marketing Authorization Holder) assessments of APQRs (Annual Product Quality Reviews)..
• Ensuring that suppliers and customers are approved.
• Approving any locally subcontracted or outsourced activities which may impact GxP.
• Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
• Preparation of audits and inspections of the local office.
• Coordination of the final disposition of returned, rejected, recalled or falsified products.
• Ensuring compliant handling of Physician Samples.
• Establishing and maintaining strong partnerships with local and regional functional groups that impact EMEA Quality and Compliance.

Required Education, Experience, and Skills 

Education:

• According to Belgian Royal Decree 14/12/2006, Art. 95 § 2:

The designated Responsible Person (RP), as defined in Article 90, paragraph 1, point 2, must hold one of the following academic degrees, obtained in accordance with applicable legislation on academic titles and university examination programs:

• A legally recognized degree in Pharmacy or a Master’s in Pharmaceutical Sciences.
• A degree in Medicine or a Master’s in Medical Sciences.
• A degree in Veterinary Medicine or a Master’s in Veterinary Sciences.
• A degree in Chemistry or a Master’s in Chemical Sciences.
• A degree in Biology or a Master’s in Biological Sciences.
• A degree in Biomedical Sciences or a Master’s in Biomedical Sciences.
• Or a degree in Bioengineering or a Master’s in Bioengineering.

Experience

• At least Minimum of 3-5 years of experience in the pharmaceutical industry, with solid quality and compliance experience.
• In-depth knowledge of Quality Management System processes and Quality Assurance including knowledge of EU GMP/GDP and local regulatory requirements, including Medical Device Regulations.
• Organizations skills.
• Fluent in English. French and/or Dutch are preferred.

Competencies required:

• Strong interpersonal and leadership skills to communicate, collaborate and influence.
• Conceptual thinking.
• High ethical standard.
• Ability to think End-to-End when analyzing problems and resolving project conflicts.

Preferred Experience and Skills 

• Experience in applications such as SAP, eQMS solutions and eLearning systems is a plus.
• Project management experience.

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