Sr Associate, Quality Assurance

Alfasigma; Alanno; In loco; EUR 42.000 - 59.000; Tempo pieno

Descrizione del lavoro

Alfasigma is seeking a Senior Associate Quality Assurance to support GMP-compliant Quality System activities and records. You will manage supplier quality agreements, CAPAs, and change controls while ensuring compliance and cross-functional collaboration across manufacturing, regulatory, and technical operations.

The role emphasizes continuous improvement, documentation rigor, and effective training within the Quality Management System to meet regulatory expectations.

Competenze

• Proven experience in Quality Assurance within GMP-regulated industries.
• Strong understanding of GMP regulations related to Quality Systems.
• Experience managing Quality Agreements, CAPAs, Change Controls, and Quality Documentation/Records.
• Fluency in written and spoken English.
• Proficiency with TrackWise, SAP, Veeva, and other eQMS tools.
• Strong analytical and problem-solving skills; results-oriented and capable of meeting deadlines.

Mansioni

• Manage and maintain Quality Agreements with suppliers, contract manufacturers, and partners.
• Coordinate CAPA processes with timely implementation, monitoring, and effectiveness verification.
• Support Change Control management including impact assessments and closures.
• Ensure GMP compliance and maintain quality documentation/records.
• Monitor training within the Quality Management System and support audits/inspections.
• Collaborate with Manufacturing, Regulatory Affairs, and other functions to drive improvements.

Conoscenze

Quality Assurance

GMP regulations

Fluency in English

Analytical skills

Problem solving

Communication skills

Teamwork

Cross-functional collaboration

Independence

Quality mindset

Formazione

Bachelor's or Master's in Chemistry/Pharmaceutical Chemistry or related field

Strumenti

TrackWise

SAP

Veeva

eQMS

Descrizione del lavoro

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Alfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquarters 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 Senior Associate Quality Assurance supports the management and continuous improvement of Quality System activities, ensuring compliance with GMP requirements, internal procedures, and regulatory expectations. This role contributes to the timely execution of quality processes and quality records, while collaborating with cross-functional teams to support operational and business needs.

The position plays a key role in maintaining the effectiveness of the Pharmaceutical Quality System through the management of Quality Agreements, CAPAs, Change Controls, and other Quality Management System initiatives.

Your Role

• Manage and maintain Quality Agreements with suppliers, contract manufacturers, and business partners.
• Coordinate and support the CAPA (Corrective and Preventive Action) process, ensuring timely implementation, monitoring, and effectiveness verification.
• Support the management of Change Controls, including impact assessments, approvals, implementation, and closure activities.
• Ensure compliance with GMP requirements and internal quality procedures.
• Maintain and support quality documentation and quality records in accordance with company standards and regulatory expectations.
• Monitor and support training compliance activities within the Quality Management System.
• Participate in supplier quality oversight activities and quality performance monitoring.
• Support self-inspections, internal audits, external audits, and regulatory inspections.
• Assist in regulatory support activities and the implementation of commitments arising from inspections and audits.
• Contribute to continuous improvement initiatives aimed at enhancing the effectiveness and efficiency of the Quality Management System.
• Collaborate effectively with Manufacturing, Supply Chain, Regulatory Affairs, Technical Operations, and other cross-functional stakeholders.

Who you are

Education

• Bachelor's or Master's Degree in a scientific discipline, such as: Chemistry, Pharmaceutical Chemistry and Technology, Chemical Engineering, Biology, Pharmaceutical Biotechnology

Experience and Technical Skills

• Proven experience in Quality Assurance within the pharmaceutical, biotechnology, or other GMP-regulated industries.
• Solid understanding of GMP regulations, particularly those related to Quality Systems.
• Experience in the management of: Quality Agreements, CAPAs, Change Controls, Quality Documentation, Quality Records
• Fluency in written and spoken English.
• Proficiency in quality and business systems such as:
• TrackWise
• SAP
• Veeva
• Other electronic Quality Management Systems (eQMS)
• Strong analytical and problem-solving skills.
• Results-oriented mindset with the ability to drive activities to completion.
• Ability to work independently while effectively managing priorities and deadlines.
• High level of accuracy, attention to detail, and organizational skills.
• Excellent communication and interpersonal skills.
• Strong teamwork and collaboration capabilities.
• Ability to build effective working relationships across departments and functions.
• Commitment to quality, compliance, and continuous improvement.

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.