Job Description

Responsibilities

Provide quality oversight support for the supplier management system -ETQ SMC module within the OMS Division, ensuring compliance with company policies, procedures, and regulatory expectations. This includes involvement in all Quality Activities supporting the ETQ SMC platform module for all Supplier related activities in support of GMP processes which are required by our Quality Standard that have potential for impact on product quality, patient safety or data integrity. Work closely with stakeholders and SMEs from Internal Manufacturing sites, DIMQ, External Manufacturing, Global Quality, Procurement, and Global Auditing to provide quality oversight throughout Supplier oversight lifecycle inclusive of qualification through ongoing monitoring and disqualification within the ETQ SMC module. Support QMS External Network topic lifecycle in regards with ETQ SMC module activities. Support creating and updating related procedures, training related documents and quality system management documents. Acts as a Business Admin of ETQ-SMC module (Approved Supplier list system): this includes creating, approving and maintaining records in the database, monitoring, investigating and resolving data discrepancies, design platform enhancements as required, and maintaining the database inspection ready. Support Business Owner activities for ETQ-SMC module Support Power BI dashboard for Supplier related subjects including the design and enhancement of new dashboard in collaboration with stakeholders and functional SMEs. Provides support to Organon using sites and functions during regulatory inspections or our Company internal audits, as requested per area of expertise. Support generation of periodic metrics for SQM across functional support areas

Required Education, Experience, and Skills

The expertise required to fulfill this role includes technical database management background and experience, data stewardship expertise (ETQ, QDM, Snowflake). In addition, the OMS ETQ SMC database is a newly designed less than one year ago module and highly configurated. Knowledge and Expertise of the legacy ST system is recommended and expertise of ETQ SMC module desired, knowledge of the supply chain management desired. At least 3 years of Quality, Operational and technical experience within a Biotechnology, Pharmaceutical, or Device Industry environment. Able to prioritize multiple initiatives. Demonstrate Collaborative leadership approach Demonstrate good judgment and logic, and influence stakeholder. Good problem-solving skills. Good written and oral communication ability. Communicate and escalate issues as necessary. Certificates B.S, in chemistry, chemical engineering, microbiology, biochemistry, biology, biological engineering, or similar scientific discipline OR equivalent combination of education and work experience.

Secondary Language(s)

Responsabilites

Supporte la gestion qualite pour le systeme de gestion des fournisseurs - module SMC ETQ au sein de la division OMS, en assurant la conformite aux politiques, procedures et attentes reglementaires de l'entreprise. Cela inclut la participation a toutes les activites de qualite soutenant la plateforme ETQ SMC pour toutes les activites liees aux fournisseurs en appui aux processus GMP exiges par notre norme de qualite et qui ont un impact potentiel sur la qualite des produits, la securite des patients ou l'integrite des donnees. Travailler en etroite collaboration avec les contacts des sites de fabrication internes, DIMQ, EQA, qualite globale, achats et audit global afin d'assurer une supervision de la qualite tout au long du cycle de vie de la supervision des fournisseurs, incluant la qualification par le suivi continu et la disqualification dans le module ETQ SMC. Soutenir le cycle de vie des fournisseurs du chapitre QMS en lien avec les activites du module ETQ SMC. Soutenir la creation et la mise a jour des procedures connexes, des documents de formation et des documents de gestion du systeme de qualite. Agit comme administrateur pour le module ETQ-SMC (systeme gerant la de liste de fournisseurs approuves) : cela inclut la creation, l'approbation et la tenue des dossiers dans la base de donnees, la surveillance, l'enquete et la resolution des divergences de donnees, l'amelioration de la plateforme de conception au besoin, et la conformite de la base de donnees. Soutenir les activites des proprietaires d'entreprise pour le module ETQ-SMC Soutenir le tableau de bord Power BI pour les sujets lies aux fournisseurs, y compris la conception et l'amelioration de nouveaux tableaux de bord en collaboration avec les parties prenantes et les experts fonctionnels. Supporte les sites et fonctions lors d'inspections reglementaires ou d'audits internes de notre entreprise, selon la demande et le domaine d'expertise. Generation de mesures periodiques pour le SQM a travers les domaines de soutien fonctionnel

Education, Experience et Competences Requises

L'expertise requise pour remplir ce role inclut une experience en gestion technique de bases de donnees, ainsi qu'une expertise en gestion des donnees (ETQ, QDM, Snowflake). De plus, la base de donnees OMS ETQ SMC est un module nouvellement concu il y a moins d'un an avec un haut niveau de configuration. La connaissance et l'expertise du systeme predecesseur ST sont recommandees, l'expertise du module ETQ SMC est souhaitee, ainsi que la connaissance de la gestion de la chaine d'approvisionnement. Au moins 3 ans d'experience en qualite, operationnelle et technique dans un environnement biotechnologique, pharmaceutique ou des instruments medicaux. Capable de prioriser plusieurs initiatives. Demontrer une approche collaborative du leadership, demontrer un bon jugement et une bonne logique, et influencer les parties prenantes. De bonnes competences en resolution de problemes. Bonne capacite en communication ecrite et orale, incluant en Anglais. Communiquez et escaladez les problemes au besoin. Certificats B.S., en chimie, genie chimique, microbiologie, biochimie, biologie, genie biologique ou discipline scientifique similaire, OU combinaison equivalente de formation et d'experience professionnelle.

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.

US and PR Residents Only

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Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status, or any other characteristic protected by state or federal law.

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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.

Applicable to United States Positions Only:

Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Annualized Salary Range (US)

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:

No

Travel Requirements:

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

No Travel Required

Flexible Work Arrangements:

Not Specified

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:

R537021