May 15, 2023

Job Description

The Compliance and Quality Systems Head is responsible for ensuring site inspection readiness by directing all aspects of site regulatory compliance and quality systems related to integration, remediation and sustainability.

This is a high visibility and demanding role, bringing with it the opportunity to learn about the company, shape global healthcare trends and have impact at the highest level.

Work location : Colleretto Giacosa – Ivrea (TO)

Your responsibilities include, but are not limited to:
• Provide oversight in the management of health authority inspections and site risk management
• Develop Health Authority communications, including written correspondence, responses to inspection observations, presentations and verbal communication
• Responsible for all Field Alert Assessments as well as primary contact for Health Authority notification of Field Alert Assessments and market withdrawals
• Provides oversight for the implementation of Quality Systems and Regulatory Compliance including management of Non conformances, CAPAs, Effectiveness Checks, Change Controls, Training, Inspections and Audit readiness, Technical complaints, Risk Assessments and remediation, Annual Product Quality review, self-assessments, KPIs and Quality Management Review
• Designs strategic site quality system and works in collaboration with Manufacturing Operations to authorize written procedures including but not limited to monitor and control of the manufacturing environment, training, document control/record retention, deviations/CAPA investigations, and monitoring compliance with all requirements of good manufacturing practice.
• Develops quality related business systems such as deviation, CAPA, OOS, product complaints and facility wide GMP training and provide critical quality expertise to transition novel gene therapies into commercially approved products.
• Develops and delivers a robust overall quality system, strategy, and ultimate plan resulting in a fully compliant quality system infrastructure with respect to procedures and processes.
• Provide strategic quality input on the translation of commercial product requirements into a technical product profile that includes defining critical quality attributes (CQAs) and critical processing parameters (CPPs).
• Provides oversight for audit and inspection management, inspection strategies, preparation, interactions and responses.
• Monitors industry observations and trends as a preventive tool to ensure compliance
• Manages a risk management program at the site level, including management of a site quality risk register

Diversity & Inclusion / EEO

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

Minimum Requirements

What you’ll bring to the role:
• B.S. degree preferably in biology or microbiology, chemistry, biochemistry or related discipline
• 10 years of related experience working in a regulated industry with 7 years of experience in pharmaceutical / biotech / bio-pharma GMP operations.
• 7 years’ experience in supervision of teams and processes is preferred, including training the team and providing continued guidance, mentorship and support.
• Expert knowledge in Quality Systems and application of the CFRs and cGMPs and ability to provide oversight for the architecture and implementation of these systems, including procedures governing these systems.
• Comprehensive knowledge of regulations (e.g., FDA, EMA) and experience in US and international regulatory agency inspections.
• Direct experience reviewing and/or authoring CMC sections of regulatory filings and partnering with operations on product related investigations and deviations.
• Strong knowledge and application of the CFRs and cGMPs and involvement in multiple regulatory inspections (familiar with multiple regulatory jurisdictions both domestically and international).
• Excellent oral and written communication skills with strong technical writing experience.
• Experience leading both internal and external vendor audits, identifying findings, driving resolution and providing closure report.

Why Advanced Accelerator Applications?

Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications (AAA), a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking 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 here at Novartis!
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: https://talentnetwork.novartis.com/network
Colleretto Giacosa
Full Time
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Compliance & Quality Systems Head

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