• 尊龙凯时

     

    Development Quality Assurance Specialist

    REQ-10060373
    8月 25, 2025
    Türkiye

    摘要

    As Development Quality Assurance Specialist you will ensure compliance with Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) across Novartis entities within a country, focusing on patient safety, data integrity, and quality oversight in both pre- and post-market settings. In this role you will collaborate with Development, Medical Affairs, and Novartis Country Quality teams to support high-quality execution of research and patient-facing programs and implement the Novartis Quality Manual and Quality Management System to maintain strong regulatory alignment and operational excellence.

    About the Role

    Location: Ataşehir, Istanbul, Turkey #Hybrid

    Novartis is unable to offer relocation support for this role: please only apply if this location is accesible for you.

    Key Responsibilities:

    • Monitor, collect, and report Quality KPIs to support timely and accurate management reviews.
    • Assist in Health Authority inspections and internal audits by providing required documentation and information.
    • Support the implementation and maintenance of the local Quality System in alignment with the Novartis Quality Manual.
    • Manage GxP Quality Assurance processes including Change Control, Training Management, Escalation, and Risk Management.
    • Ensure full compliance with GxP standards and Novartis Quality procedures across all quality-related activities.
    • Track and ensure timely completion of CAPAs, escalating unresolved issues as needed.
    • Review quality deliverables for compliance with SOPs and regulatory requirements, including third-party work and clinical materials.
    • Prepare, release, and archive GxP documentation; support inspection readiness and compliance reviews.

    Essential Requirements:

    • University degree in Life Sciences, Pharmacy or related field.
    • 3 years of experience in Clinical or Pharmacovigilance activities is preferred.
    • Strong knowledge of GxP, CAPA, Risk Management, SOPs, and Quality Management Systems (QMS).
    • Skilled in Audit Management, Change Control, Root Cause Analysis, and Health Authority interactions.
    • Demonstrated agility, influencing skills, and ability to collaborate across boundaries.
    • Technological proficiency and self-awareness in a regulated environment.
    • Fluent in English and Turkish.

    Commitment to Diversity & Inclusion:
    Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
    Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

    Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? http://www.novartis.com/about/strategy/people-and-culture

    Join our Novartis Network: 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: http://talentnetwork.novartis.com/network

    Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards

    Development
    Innovative Medicines
    Türkiye
    Istanbul Ataşehir
    Quality
    Full time
    Regular
    No

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

    A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.
    REQ-10060373

    Development Quality Assurance Specialist

    Apply to Job

    Source URL: http://m.jindumilan.com/careers/career-search/job/details/req-10060373-development-quality-assurance-specialist

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    2. http://talentnetwork.novartis.com/network
    3. http://www.novartis.com/careers/benefits-rewards
    4. http://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Istanbul-Ataehir/Development-Quality-Assurance-Specialist_REQ-10060373-2
    5. http://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Istanbul-Ataehir/Development-Quality-Assurance-Specialist_REQ-10060373-2