QA Regulatory & Compliance Manager

Novo Nordisk A / S; Frosinone; In loco; EUR 60.000 - 80.000; Tempo pieno

Descrizione del lavoro

Novo Nordisk is seeking a QA Regulatory & Compliance Manager for its facility in Anagni, Italy. In this role, you will ensure compliance with global regulatory standards and Good Manufacturing Practices (GMP), and lead inspection readiness activities. Ideal candidates will have over 10 years of experience in Quality Assurance, strong leadership skills, and an in-depth understanding of regulatory requirements. This position offers an opportunity to be part of a growing team dedicated to delivering excellence in patient care.

Servizi

Inclusive recruitment process

Opportunities for professional development

Competenze

• Minimum of 10 years of experience in Quality Assurance in the pharmaceutical industry.
• Experience in Health Authority inspections.
• Solid knowledge of EU and US regulatory requirements.

Mansioni

• Lead preparation and coordination of inspections by Health Authorities.
• Manage communications and notifications to regulatory authorities.
• Oversee core quality systems including Change Control and internal audits.

Conoscenze

Regulatory Compliance

Inspection Readiness

Quality Management Systems (QMS)

Team Leadership

Data Integrity Governance

Formazione

University degree in scientific disciplines

Descrizione del lavoro

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Category : Reg Affairs & Safety Pharmacovigilance

At the end of 2024, Novo Nordisk acquired the Catalent Anagni S.r.l. manufacturing site with the ambition of expanding our capacity to meet the needs of millions of patients. You will be joining a global team working on pharmaceutical plants that utilize advanced technologies within the site's fill & finish facilities.

At Novo Nordisk, we don't wait for change—we drive it!

Today we are looking for a QA Regulatory & Compliance Manager to join our team in Anagni and play a key role in ensuring that our quality systems is fully aligned with cGMP, regulatory expectations and patient safety standards.

The Position

As a QA Regulatory & Compliance Manager, you will be a key leader within the Quality organization, responsible for ensuring the site's compliance with global regulatory requirements and Good Manufacturing Practices (GMP). Operating in a dynamic, cross-functional environment, you will drive inspection readiness, regulatory compliance, and the continuous improvement of the Quality Management System (QMS), supporting strategic quality initiatives and maintaining a strong compliance culture.

Key Responsibilities

• Health Authority (HA) Inspection Readiness : Lead the preparation and coordination of inspections by national and international Health Authorities (e.g., AIFA, FDA, EMA). Ensure implementation of a robust inspection readiness program, oversee response strategies, and manage the development and follow-up of effective CAPA plans.
• Regulatory Compliance Support : Support site Qualified Persons (QPs) in managing regulatory activities. Coordinate with internal functions to gather and maintain documentation required for product registration, variations, and regulatory submissions.
• Regulatory Communication & Documentation : Manage communications and notifications to regulatory authorities (e.g., AIFA, FDA), ensuring timely and accurate submissions. Own and maintain the Site Master File (SMF), ensuring its continuous alignment with evolving global regulatory expectations.
• Quality Systems Oversight : Oversee core quality systems including Change Control, Annual Product Quality Review (APQR), internal audit programs, and Periodic Quality Reviews. Ensure accurate data collection and reporting of QA Key Performance Indicators (KPIs).
• Data Integrity Governance : Coordinate the site’s Data Integrity Program. Ensure alignment with corporate quality standards and regulatory expectations. Provide oversight for QMS processes to assure data integrity compliance across all GxP areas.
• Computer System Validation (CSV) : Oversee validation strategies and plans for GxP-relevant computerized systems in line with global regulations (FDA, EMA). Review and approve validation documentation (IQ / OQ / PQ protocols and reports) to ensure consistency and compliance.
• Quality Culture & Leadership : Champion a proactive quality culture across the site. Provide leadership, training, and support to cross-functional teams to strengthen compliance, enhance inspection readiness, and drive continuous improvement.

Qualifications & Profile

To be successful in this role, we imagine that you have :

• University degree in scientific disciplines (e.g., Pharmacy, Chemistry, Biotechnology, Biology, CTF).
• Minimum of 10 years of experience in Quality Assurance in the pharmaceutical industry, with a strong focus on regulatory compliance, inspection readiness, and QMS.
• Proven experience in Health Authority inspections, including leading preparation, managing inspections on-site, and coordinating post-inspection activities.
• Solid knowledge of EU (AIFA / EMA) and US (FDA) regulatory requirements, GMP standards, and validation principles (IQ / OQ / PQ).
• Experience in maintaining and updating the Site Master File, managing the APQR process, and leading internal audits and quality reviews.
• Demonstrated expertise in Data Integrity compliance and governance of GxP computerized systems.
• Fluent in English with excellent communication and interpersonal skills, capable of interfacing with regulatory authorities and cross-functional teams.
• Strong leadership skills with the ability to influence, mentor, and guide teams.

About the Department

You’ll lead a fantastic team made up of 3 direct reports and 7 indirect colleagues, playing a key leadership role within a wider group of 6 QA Managers in different functions. You’ll report directly to the Quality Operations Director and contribute to the growth of a rapidly expanding business unit : currently composed of over 190 passionate professionals dedicated to delivering excellence.

Working at Novo Nordisk

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.

Contact

We can’t accept directly sent CVs, please submit your application via the ‘Apply’ Button.

Deadline

Apply before June 18, 2025.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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