Job Description
Senior Specialist, Compliance officer (interne Auditor)
Welkom bij ons team
De Senior Compliance Officer rapporteert aan de Site Lead Auditor.De rol omvat intensieve samenwerking binnen de site op alle niveaus: van operatoren en analisten tot managers, directors en de plant manager. Daarnaast zijn er internationale contacten met collega’s uit andere vestigingen en centrale kwaliteitsfuncties. Extern onderhoudt de functiehouder contacten met kwaliteitsverantwoordelijken van klanten en partners bij audits, en in het kader van Technical/Quality Agreements. Ook is er mogelijk contact met inspecteurs van overheidsinstanties zoals het FAGG, EMA, FDA en andere nationale of internationale gezondheidsautoriteiten.
Doel van de functie
Mee instaan voor de implementatie, borging en naleving van geldende GMP-richtlijnen en interne kwaliteitsstandaarden binnen de organisatie, en de goedkeuring en opvolging van externe leveranciers
Primaire verantwoordelijkheden
- Uitvoeren van interne Site Quality Audits en Walk-Through Audits binnen productie- en kwaliteitsafdelingen, inclusief evaluatie en opvolging van CAPA’s.
- Voorbereiden, coördineren en begeleiden van inspecties door overheidsinstanties en externe partijen.
- Opstellen en coördineren van antwoorden en CAPA-plannen naar aanleiding van inspectie-observaties, inclusief opvolging van implementatie.
- Ontwikkelen en beheren van het interne auditprogramma en opvolging van de uitvoering.
- Rapporteren over kwaliteitsissues, risico’s en verbetervoorstellen aan site management.
- Opvolgen van wijzigingen in GMP-regelgeving en relevante wetgeving.
- Fungeren als Subsystem Owner binnen het kwaliteitssysteem Audits & Inspecties.
- Actief bijdragen aan continue verbetering via teammeetings, optimalisatievoorstellen en kaizen-initiatieven.
- Opstellen en beheren van Technical/Quality Agreements met externe partners, loonwerkers en andere sites.
- Uitvoeren van leverancierskwalificaties van leveranciers en service providers.
Jouw profiel
- Master of bachelor in een wetenschappelijke richting, of gelijkwaardig door ervaring.
- Ervaring met kwaliteitssystemen binnen farmaceutische productie (GMP).
- Ervaring met audits, inspecties en regulatory vereisten binnen een farmaceutische context.
- Ervaring in projectmatig werken en coördinatie van multidisciplinaire opdrachten.
- Sterk analytisch vermogen, nauwkeurig en gestructureerd.
- Goede kennis van Nederlands en Engels, mondeling en schriftelijk.
- Sterke communicatieve vaardigheden en diplomatische aanpak.
- Zelfstandig, resultaatgericht en overtuigend in stakeholdermanagement.
- Affiniteit met kwaliteitsverbetering, regelgeving en compliance
Wij bieden
Werken bij onze organisatie betekent meebouwen aan gezondheid in een internationale omgeving, samen met betrokken collega’s. Je krijgt ruimte om jezelf te ontwikkelen en initiatief te nemen.
Je kan rekenen op:
- een uitdagende functie met veel autonomie
- een competitief salaris
- hospitalisatieverzekering
- een aantrekkelijk pensioenfonds
- maaltijdcheques
- 41 vakantiedagen
- een bonussysteem
- extra legale voordelen
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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
No Travel RequiredFlexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
Hazardous Material(s):
Number of Openings:
1Organon Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Organon and has not been reviewed or approved by Organon.
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Strong & Reliable Incentives — Quarterly bonuses and performance-based long-term incentives are frequently emphasized as meaningful components of total rewards, sometimes contrasted favorably with larger pharmaceutical firms. Recognition programs and an annual incentive process reinforce a pay-for-performance approach.
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Parental & Family Support — Twelve weeks of gender-neutral paid parental leave and twenty days of bereavement leave, including coverage for pregnancy loss, signal a robust family support offering. Caregiving concierge services and flexible leave practices further strengthen support for caregiving needs.
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Retirement Support — Retirement plans include employer contributions across many markets, with U.S. materials highlighting matching and additional company retirement contributions. This structure is presented as a core part of the financial benefits package.
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What We Do
Organon is a global healthcare company with a portfolio of therapies and products in women’s health, biosimilars, and established medicines across a wide array of conditions and diseases. Our mission is to deliver impactful medicines and solutions for a healthier every day. This site is intended for residents of the United States and its territories. You are reminded to protect yourself against recruiting fraud from individuals, organizations or other entities claiming to represent Organon. All official Organon recruitment emails will come from accounts formatted as [email protected] or [email protected], and Organon will never conduct interviews by chat or email, or make job offers through social media or online forums. All candidates for roles at Organon will first meet with a recruiter and interview team, via Teams or in person. Organon will never ask you to make financial transactions on its behalf or ask you to receive or ship packages or goods. For more information on adverse event reporting, visit http://bit.ly/AEReporting. To read our community guidelines, visit http://bit.ly/OrganonCommunityGuidelines. Follow us on Twitter at Organon (@OrganonLLC). Follow us on Instagram at Organon (@OrganonLLC).
