Specialist, Supplier & ESO Quality Operations - 1y Temporary Maternity Cover

Alfasigma group; Lombardia; In loco; EUR 36.000 - 44.000; Tempo pieno

Descrizione del lavoro

Alfasigma invites applications for a Specialist, Supplier & ESO Operations. You will support quality oversight across the product lifecycle, manage quality events, investigations, CAPAs and risk assessments to ensure regulatory compliance.

The role requires experience with supplier qualification, audits, quality systems, and digital tools (eQMS, SAP, TrackWise, Veeva). Fluent English is essential; Italian familiarity is a plus. Join a global Italy-based leader in GI health.

Competenze

• 3+ years of supplier quality management experience in pharma, food supplements or devices.
• Strong GMP, GDP, ISO 9001/13485 knowledge.
• Experience with supplier qualification, audits, risk management and quality systems.
• Experience with digital quality systems (eQMS, SAP, TrackWise, Veeva) and process improvement.
• Fluent in English; other languages are a plus.

Mansioni

• Oversee supplier quality and compliance across the product lifecycle.
• Manage quality events, investigations, CAPAs, and risk assessments.
• Coordinate change control activities affecting suppliers and manufacturing.
• Support product disposition and release decisions with proper documentation.
• Maintain supplier qualification, audits, and Quality Agreements.
• Support continuous improvement and technology transfers.

Conoscenze

Quality management

Supplier oversight

GMP knowledge

Regulatory compliance

Data analysis

Communication

Team collaboration

English fluency

Formazione

Bachelor's degree in Pharmacy

Bachelor's degree in Chemistry

Bachelor's degree in Life Sciences

Bachelor's degree in Engineering

Strumenti

eQMS

SAP

TrackWise

Veeva

Descrizione del lavoro

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Specialist, Supplier & ESO Quality Operations - 1y Temporary Maternity Cover

Alfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa.

Over three years ago, we embarked on a transformative journey to become a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health. We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities.

But our journey is far from complete! In fact, this is just the beginning of a bold new chapter in Alfasigma's history. We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets.

Scope of the Role

The Specialist, Supplier & ESO Operations supports quality oversight and compliance activities across the product lifecycle. The role is responsible for managing quality events, investigations, risk assessments, and change controls to ensure compliance with company requirements. The position also supports quality performance monitoring, issue resolution, and lifecycle management activities.

Your Role

As Specialist, Supplier & ESO Operations, you will:

• Support the quality oversight of assigned suppliers to ensure compliance with applicable regulations, quality standards, and company requirements throughout the product lifecycle.
• Manage supplier oversight, quality events, and risk management activities, including complaints, deviations, investigations, CAPAs, risk assessments, and OOS/OOT results, ensuring timely resolution of quality issues and effective mitigation of quality risks.
• Coordinate change control activities impacting suppliers, manufacturing processes, materials, and externally manufactured products, ensuring compliant implementation and effective cross-functional alignment.
• Support product disposition and release decisions by ensuring that quality issues, investigations, deviations, and changes are appropriately assessed, documented, and resolved in accordance with applicable requirements.
• Maintain supplier qualification, audit readiness, and ongoing compliance through supplier oversight activities, participation in audit programs, management of corrective action plans, and Quality Agreements.
• Support continuous improvement and technical quality initiatives by identifying process enhancement opportunities, supporting technology transfers and remediation projects, and collaborating with internal and external stakeholders to strengthen quality performance and compliance.

Who You Are

Work Experience

• 3+ years of experience in supplier quality management within pharmaceuticals, food supplements, or medical devices.

Education & Training

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or Engineering.
• Strong knowledge of GMP, GDP, ISO 9001, ISO 13485, and applicable regulations for pharmaceuticals, medical devices, and food supplements.
• Solid experience in supplier qualification, supplier oversight, audits, risk management, and quality systems within a regulated environment.
• Experience with digital quality systems (eQMS, SAP, TrackWise, Veeva, or similar) and process improvement initiatives.
• Good analytical skills, including KPI monitoring, performance reporting, and data analysis.
• Strong communication and collaboration skills, with the ability to work effectively with internal teams and external partners.
• Experience supporting quality improvement projects, technology transfers, and the resolution of complex quality issues.
• Fluent in English, both written and spoken; additional languages are considered an advantage.

The pay range is around €40,000

The compensation range indicated in this job posting represents an estimated average range for the position. The final remuneration will be determined based on the selected candidate’s experience, skills, and qualifications, in accordance with applicable EU pay transparency and pay equity requirements

Why Join Alfasigma:

At Alfasigma, we foster a culture where the courage to innovate is key to our success.
We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development.

Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress.

Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry.