Development Quality Manager in Pharma

1 week ago

Bucharest, Bucureşti, Romania Novartis Full time 900,000 - 1,200,000 per year

Job Description Summary

Internal job title: Development Quality Assurance Manager
Location: Warsaw (Poland) / Bucharest (Romania)

The Development Quality Assurance Manager is responsible for assuring quality oversight of activities undertaken in all Novartis entities in a country to ensure they are conducted in compliance with relevant Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) regulations and guidelines.

Operates in direct collaboration with local Development colleagues (Study and Site Operations, Patient Safety and Regulatory Affairs), Medical Affairs, Novartis Country Quality (NCQ) & Commercial teams for patient-facing projects, products and programs. Ensures implementation of the Novartis Quality Manual and Quality Management System in the country to achieve a high level of quality and compliance.

This position is part of Global Development Country Quality team and reports directly into Head, Clin&PV Region/Cluster Quality GDQ.

#LI-Hybrid

Job Description

Major accountabilities:

  • Oversee implementation, maintenance, and monitoring of the local Quality System and Quality Plan to ensure compliance with Novartis global requirements and applicable local regulations.

  • Ensure adequate training systems are in place for GCP, GPvP, and other relevant Development activities.

  • Monitor local Quality System, processes, and Key Quality Indicators (KQIs) to proactively identify potential quality risks and collaborate with business partners to address them.

  • Partner with local and global Development teams in the execution and follow-up of quality issues and audits related to clinical development and PV activities, ensuring robust corrective and preventive actions are implemented.

  • Provide leadership and support for GCP and GPvP Health Authority (HA) inspections, ensuring timely submission of responses to local HA and completion of CAPAs.

  • Execute QA activities required for the qualification and monitoring/governance of third party activities with a clinical/medical or PV component.

Minimum Requirements:

  • Degree in Life Sciences or related fields

  • Solid experience in the pharmaceutical industry in a relevant field such as quality assurance, regulatory affairs, pharmacovigilance or a directly related area, ideally with several years of experience in clinical development.  

  • Excellent verbal and written communication skills, capable of delivering messages in a clear, concise, and convincing manner.

  • Proven track record in leading projects and stakeholders-management

  • Full professional proficiency in English and native proficiency in Polish or/and Romanian

Benefits and Rewards:

Read our handbook to learn about all the ways we'll help you thrive personally and professionally: Novartis Life Handbook

Commitment to Diversity and Inclusion / EEO:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve

Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:  

Skills Desired

  • Quality Assurance

    1 week ago

    Bucharest, Bucureşti, Romania Medison Pharma Full time 96,000 - 144,000 per year

    Medison offers hope to patients suffering from rare and severe diseases, by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead, and work relentlessly to bring therapy...

  • Key Account Manager

    1 week ago

    Bucharest, Bucureşti, Romania GENESIS Pharma Full time 30,000 - 60,000 per year

    About usEstablished in 1997, by a group of people who recognized early on the power and potential of pharmaceutical biotechnology, GENESIS Pharma was the first pharmaceutical company in Greece and one of the first in Europe to focus on the commercialization of new and innovative biopharmaceutical products. Shortly after its founding, the company began to...

  • Key Account Manager Rare Disease

    1 week ago

    Bucharest, Bucureşti, Romania Medison Pharma Full time €30,000 - €60,000 per year

    Medison offers hope to patients suffering from rare and severe diseases, by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead, and work relentlessly to bring...

  • Key Account Manager, Oncology

    1 week ago

    Bucharest, Bucureşti, Romania Medison Pharma Full time 40,000 - 80,000 per year

    Medison offers hope to patients suffering from rare and severe diseases, by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead and work relentlessly to bring...

  • Key Account Manager Rare Disease

    1 week ago

    Bucharest, Bucureşti, Romania Medison Pharma Full time €60,000 - €120,000 per year

    Medison offers hope to patients suffering from rare and severe diseases, by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead, and work relentlessly to bring therapy...

  • NetSuite Expert

    1 week ago

    Bucharest, Bucureşti, Romania Medison Pharma Full time 40,000 - 80,000 per year

    Medison offers hope to patients suffering from rare and severe diseases, by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead, and work relentlessly to bring...

  • Pharma Procurement Specialist

    7 hours ago

    Bucharest, Bucureşti, Romania PHARM AHEAD SRL Full time

    Domeniu: Produse farmaceutice și cosmeticeLocație: BucurestiTip contract: Full-timeDescrierea rolului:Căutăm un profesionist experimentat în achiziții și management de furnizori care să se alăture echipei noastre și să contribuie la dezvoltarea portofoliului de produse farmaceutice și cosmetice prin canale directe si de import paralel din...

  • Director of Global Indirect Procurement

    1 week ago

    Bucharest, Bucureşti, Romania Medison Pharma Full time €60,000 - €150,000 per year

    Medison offers hope to patients suffering from rare and severe diseases, by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets. As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead and work relentlessly to bring...

  • Sourcing & Purchasing Specialist (Pharmaceuticals)

    1 week ago

    Bucharest, Bucureşti, Romania Pharma Vision Plus - România Full time 20,000 - 60,000 per year

    Pharma Vision Plus SRL, a trusted Romanian pharmaceutical wholesaler and proud member of the Romanian Association of Euro-Pharmaceuticals Wholesalers (ADEM Romania) and Affordable Medicines Europe, is looking for a Sourcing & Purchasing Specialist to join our team in Bucharest.Role overview:The Sourcing & Purchasing Specialist will be responsible for...

  • Reprezentant Vânzări – Soluții pentru biosecuritate și siguranță alimentară în industria alimentară și ferme

    6 days ago

    Bucharest, Bucureşti, Romania Pharma ONE Romania Full time 60,000 - 120,000 per year

    Descrierea postului:Pharma One, prin diviziaBioHygiene, specializată în furnizarea de soluții profesionale integrate pentru biosecuritate și siguranță alimentară, își extinde echipa de vânzări.Căutăm unprofesionist cu experiențăcare să se alăture echipei noastre și să promoveze produse și soluții tehnice destinatefabricilor procesatoare...