QA Digital Compliance Manager

AbbVie; Italia; In loco; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

AbbVie is looking for a QA Digital Compliance Manager in Italy. This role involves ensuring compliance of digital systems with regulatory standards, overseeing data integrity, and supporting cybersecurity measures. Candidates should hold a degree in Life Sciences or IT and have 5-10 years of digital compliance experience in the pharmaceutical industry, alongside strong communication and managerial skills. The role offers an opportunity to make a significant impact on organizational compliance and data integrity.

Competenze

• Bachelor's degree in Life Sciences, IT or related field; master’s degree preferred.
• 5–10+ years of experience in digital compliance applied in the pharmaceutical industry.
• Strong knowledge of pharmaceutical regulations (FDA, EMA, etc.).
• Excellent communication and training skills.
• Fluent English language.
• Analytical mindset and attention to detail.
• Experience in managerial roles in complex organizations.

Mansioni

• Monitoring and ensuring adherence to relevant regulatory bodies for digital content and initiatives.
• Ensuring and maintaining quality oversight of data integrity and traceability across computerized systems.
• Supporting the implementation of cybersecurity measures to protect data.
• Serving as a subject-matter expert for training employees on digital compliance requirements.
• Ensuring that software and digital tools used in operations are validated and documented.
• Supporting the development and update of digital compliance policies and procedures.
• Collaborating with global and local IT to maintain compliant digital strategies.
• Investigating and responding to non-compliance events.

Descrizione del lavoro

Job Description

The QA Digital Compliance Manager is responsible for ensuring that all digital systems, records, instruments, processes and data handling within operations adhere to relevant regulatory, legal, best practices and industry standards.

Key Responsibilities

• Monitoring and ensuring adherence to relevant regulatory bodies (e.g. FDA, EMA) for digital content and initiatives in compliance with regulations like FDA 21 CFR Part 11 and EU Annex 11, and keeping updated with evolving digital compliance regulations and trends (e.g. Annex 22 about AI).
• Ensuring and maintaining quality oversight of data integrity and traceability across the lifecycle of computerized systems such as manufacturing execution systems, laboratory information management systems (LIMS), electronic lab notebooks (ELN/LES), and instrument software.
• Supporting the implementation of proper cybersecurity measures to protect data and prevent unauthorized access or tampering.
• Serving as a subject‑matter expert for training employees and stakeholders on digital compliance requirements and best practices, and for auditing digital systems to ensure adherence to GMP, company policies and other relevant standards, including risk assessments, supplier qualification and periodic system audit‑trail reviews.
• Ensuring that software and digital tools used in operations are validated and documented according to regulatory and company requirements through the review and approval of validation documents.
• Supporting the development, review and update of digital compliance policies and procedures.
• Collaborating with global and local IT, BTS and all relevant functions to maintain compliant digital strategies.
• Investigating and responding to non‑compliance events and contributing to change management and lifecycle handling.

Qualifications

• Bachelor's degree in Life Sciences, IT or related field; master’s degree preferred.
• 5–10+ years of experience in digital compliance applied in the pharmaceutical industry.
• Strong knowledge of pharmaceutical regulations (FDA, EMA, etc.).
• Excellent communication and training skills.
• Fluent English language.
• Analytical mindset and attention to detail.
• Experience in managerial roles in complex organizations.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only – to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html