Information Technology Quality Assurance Manager

Olon; Rodano; In loco; EUR 80.000 - 120.000; Tempo pieno

Vantaggi offerti da questo lavoro

Dynamic work environment

Training programs

Internal career paths

Inclusive workplace

Descrizione del lavoro

A leading pharmaceutical company located in Lombardia, Italy, is seeking an IT Quality, Compliance and Validation Manager. This role involves overseeing the GxP systems validation lifecycle, ensuring compliance with regulatory standards, and supporting audits. Ideal candidates should have a bachelor's degree and 3-5 years of experience in the pharma or biotech industries, alongside strong analytical and leadership skills. The company promotes a dynamic, inclusive work environment, with opportunities for personal growth.

Competenze

• 3-5 years of experience in a similar role within the Pharmaceutical or Biotech industries.
• Detail-oriented mindset with independent problem-solving ability.
• Strong organizational and planning skills.
• Excellent English communication skills.

Mansioni

• Oversee the GxP systems validation lifecycle for compliance.
• Prepare and approve validation protocols and reports.
• Develop validation procedures to align with regulatory requirements.
• Support internal and external audits and inspections.
• Provide IT quality assessments for deviations and non-conformities and support CAPA activities.
• Author and maintain SOPs and work instructions for IT system compliance.
• Ensure proper CSV processes during system implementations and provide CSV support for new IT projects.
• Support internal and external audits/inspections and manage regulatory authority interactions.

Conoscenze

Regulatory Knowledge

Technical Writing

Data Analysis

Leadership

Formazione

Bachelor's degree or higher

Descrizione del lavoro

Olon Group is a global leader in the development and production of active pharmaceutical ingredients (APIs) for CDMO and generic markets, integrating chemical synthesis and biological processes while always embracing the highest international safety, quality, and environmental standards.

Olon operates 14 manufacturing sites and 14 R&D centers across the globe.

In order to strengthen the IT team dedicated to Compliance, we are looking for an IT Quality, Compliance and Validation Manager.

Key Responsibilities

• Oversee the entire GxP systems validation lifecycle, ensuring that software and IT infrastructure operate as intended and in compliance with GAMP 5 standards and FDA 21 CFR Part 11 regulations.
• Develop and maintain validation procedures to ensure continuous alignment with current regulatory requirements.
• Prepare, execute, and approve validation protocols and reports (IQ/OQ/PQ).
• Identify, assess, and mitigate risks related to data integrity, cybersecurity, and system performance.
• Provide IT support and quality assessments for deviations and non-conformities.
• Recommend, implement, and oversee corrective and preventive actions (CAPAs) to strengthen IT compliance.
• Author and maintain Standard Operating Procedures (SOPs) and work instructions related to IT system compliance.
• Ensure proper CSV processes during system implementations and offer CSV support for new IT projects throughout the entire project lifecycle.
• Support internal and external audits and inspections, manage interactions with regulatory authorities (e.g., FDA, AIFA), and ensure timely closure of findings through effective CAPA plans.
• Manage user profiling on validated systems, including documentation of profile creation, modification, and deactivation requests, technical implementation, and verification of compliance with requirements.

Required Skills (Hard & Soft Skills)

• Regulatory Knowledge: Solid understanding of GAMP, Annex 11, GxP, and relevant ISO standards.
• Technical Writing: Ability to draft and approve validation protocols, test plans, and final reports.
• Data Analysis: Capability to use analytical tools to monitor quality KPIs and identify trends or deviations.
• Leadership: Strong ability to coordinate cross-functional teams and promote IT quality and compliance culture across the organization.

Your Background and Experience

• A bachelor’s degree or higher.
• A minimum of 3–5 years of experience in a similar role within the Pharmaceutical or Biotech industries, or in specialized consulting firms.
• A detail-oriented mindset and the ability to independently resolve a variety of issues with minimal supervision.
• Strong organizational and planning skills.
• A collaborative approach and ability to work effectively in team environments.
• Excellent English communication skills (verbal, written, and interpersonal).

You will find:

• 🚀 A dynamic, constantly evolving work environment, open to creativity and personal contribution
• 📜 Training Program to increase your personal and professional skills
• 🎓 Courses for recent high school graduates and graduates
• 💼 Internal career paths: we believe in internal growth and cultivate our managers
• 🌍 An inclusive environment that fosters integration of different cultures and mindsets

Olon is committed to providing equal opportunities in employment. Our policy foresees that equal employment opportunities are provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status and/or any legally recognized status entitled to protection under applicable local laws.