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) Job Description
Responsabilités
* Supporte la gestion qualité pour le système de gestion des fournisseurs - module SMC ETQ au sein de la division OMS, en assurant la conformité aux politiques, procédures et attentes réglementaires de l’entreprise. Cela inclut la participation à toutes les activités de qualité soutenant la plateforme ETQ SMC pour toutes les activités liées aux fournisseurs en appui aux processus GMP exigés par notre norme de qualité et qui ont un impact potentiel sur la qualité des produits, la sécurité des patients ou l’intégrité des données.
* Travailler en étroite collaboration avec les contacts des sites de fabrication internes, DIMQ, EQA, qualité globale, achats et audit global afin d’assurer une supervision de la qualité 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 activités du module ETQ SMC.
* Soutenir la création et la mise à jour des procédures connexes, des documents de formation et des documents de gestion du système de qualité.
* Agit comme administrateur pour le module ETQ-SMC (système gérant la de liste de fournisseurs approuvés) : cela inclut la création, l’approbation et la tenue des dossiers dans la base de données, la surveillance, l’enquête et la résolution des divergences de données, l’amélioration de la plateforme de conception au besoin, et la conformité de la base de données.
* Soutenir les activités des propriétaires d’entreprise pour le module ETQ-SMC
* Soutenir le tableau de bord Power BI pour les sujets liés aux fournisseurs, y compris la conception et l’amélioration de nouveaux tableaux de bord en collaboration avec les parties prenantes et les experts fonctionnels.
* Supporte les sites et fonctions lors d’inspections réglementaires ou d’audits internes de notre entreprise, selon la demande et le domaine d’expertise.
* Génération de mesures périodiques pour le SQM à travers les domaines de soutien fonctionnel
Éducation, Expérience et Compétences Requises
* L’expertise requise pour remplir ce rôle inclut une expérience en gestion technique de bases de données, ainsi qu’une expertise en gestion des données (ETQ, QDM, Snowflake). De plus, la base de données OMS ETQ SMC est un module nouvellement conçu il y a moins d’un an avec un haut niveau de configuration.
* La connaissance et l’expertise du système prédécesseur ST sont recommandées, l’expertise du module ETQ SMC est souhaitée, ainsi que la connaissance de la gestion de la chaîne d’approvisionnement.
* Au moins 3 ans d’expérience en qualité, opérationnelle et technique dans un environnement biotechnologique, pharmaceutique ou des instruments médicaux. Capable de prioriser plusieurs initiatives.
* Démontrer une approche collaborative du leadership, démontrer un bon jugement et une bonne logique, et influencer les parties prenantes.
* De bonnes compétences en résolution de problèmes.
* Bonne capacité en communication écrite et orale, incluant en Anglais. Communiquez et escaladez les problèmes au besoin.
* Certificats B.S., en chimie, génie chimique, microbiologie, biochimie, biologie, génie biologique ou discipline scientifique similaire, OU combinaison équivalente de formation et d’expérience 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
For more information about personal rights under Equal Employment Opportunity, visit:
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.
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