Project Quality Management Expert

Oct 01, 2021
Czech Republic

Job Description

Project Quality Management Expert, Novartis, Prague, Czech Republic

1! Excellent opportunity to join our NBS IT team. As the Project Quality Manager you will ensure alignment and consistency across the IT, business, service provider and other partners on quality and compliance for the IT projects. You will deliver Quality management services to the NBS IT division and its Customers to ensure that information assets are adequately protected and compliant.

Your key responsibilities:
Your responsibilities include, but are not limited to:
• Lead project compliance work streams. Be responsible for end to end quality and compliance aspect of the project and validation deliverables.
• Lead compliance of the system during its lifecycle, with regards to Regulatory and Novartis Internal Standards. Perform document reviews & coordination of various activities including testing.
• Provide GxP related validation expertise and Partner with key business stakeholders (i.e. Manufacturing, Quality, Validation, Risk and Compliance, etc.). Create, review, update and approve CSV deliverables including Validation Assessment, Validation Plan, Test Plan, Qualification scripts (IQ, OQ, PQ), Test protocols and reports, Traceability Matrix and Validation Summary Report.
• Supervise and control validation process to ensure timely and cost-effective delivery of the system to the business users. Identify and log issues found during validation execution, perform root-cause analysis to define corrective and preventive measures to be taken.
• Provide compliance & risk management guidance for IT projects, including the evaluation, implementation and monitoring of information security controls.
• Support Audits, Inspections and Assessments performed by internal and external agencies. Evaluate the risks arising from control deficiencies, gaps and facilitates risk mitigation planning.
• Act as the first point of contact for all quality related queries on the projects, follow-up resolution of identified quality exposures and partner concern to line management if critical situations are not resolved in due course.

Diversity & Inclusion / EEO

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

Minimum Requirements

What you’ll bring to the role:
• Bachelor’s degree in Engineering/ Sciences or relevant technical experience; knowledge on Waterfall, Agile and DevOps methodology
• 8+ years of working experience in IT Quality management / Information Security and Risk management / service delivery positions in regulated environment / pharma / life sciences
• Experience working within the guidelines provided by regulatory agencies such as FDA, MHRA, etc. on one or more of the following areas: CFR Title 21 (parts 11, 210, and 211), Annex 11, GAMP, V-Model, CAPA, GxP (GMP, GLP, GCP, GVP, etc.), ERES regulations and Computer Systems Validation (CSV) coupled with ability to apply the same.
• Familiar with compliance requirements (e.g. SOX, FDA/GxP, GQO, COBIT, Records Management, Privacy, Legal, BCM/Disaster Recovery); solid understanding of Risk Management, Audit management and periodic or control maturity assessment; knowledge of various Requirement management and Test management tools (like HPALM, Jira, Confluence, etc.) and templates used throughout the Pharmaceutical industry
• Experience with cloud-based applications, Documentum, enterprise applications and Infrastructure services is a plus; should have adequate understanding on Change Management and Change Control Procedures, Deviation Handling, and CAPA management; Risk management background with experience in risk management related roles

You’ll receive:
Monthly pension contribution matching your individual contribution up to 3% of your gross monthly base salary; Risk Life Insurance (full cost covered by Novartis); 5-week holiday per year; (1 week above the Labour Law requirement) ; 4 paid sick days within one calendar year in case of absence due to sickness without a medical sickness report; Cafeteria employee benefit program – choice of benefits from Edenred CZ in the amount of 12,500 CZK per year; Meal vouchers in amount of 90 CZK for each working day (full tax covered by company); Public Transportation allowance; MultiSport Card. Find out more about Novartis Business Services:

Why consider Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do at Novartis!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
Czech Republic
Information Technology
Full Time
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Project Quality Management Expert

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