Sr Associate, QA Compliance & System

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 Quality Compliance Specialist, reporting directly to the Quality Compliance Coordinator, will be part of a team of three people and will play a key role in the management and continuous improvement of the electronic Quality Management System (eQMS). The role focuses on ensuring the effective management of training records, document control, procedural workflows, and the CAPA system, while maintaining full compliance with GMP requirements and internal Quality System standards. Working closely with Quality Assurance and other internal and external stakeholders, the position contributes to strengthening the company’s quality culture and ensuring regulatory compliance across the organization.

Your Role
In this role, you will support the implementation, maintenance, and continuous improvement of the Quality Management System, with a strong focus on training compliance, CAPA management, and document control processes. Main Responsibilities:

• Manage the training process within the eQMS, ensuring accurate maintenance of training records and compliance with regulatory requirements.

• Identify and assess training needs across departments.

• Prepare, deliver, and monitor training materials and programs, including GMP and compliance-related topics.

• Evaluate the effectiveness of training programs and implement improvements where necessary.

• Act as a GMP subject matter expert and support the continuous improvement of training effectiveness.

• Mentor and support colleagues, fostering a strong quality and compliance culture.

• Oversee the CAPA (Corrective and Preventive Actions) process, including tracking, follow-up, effectiveness checks, and timely closure.

• Participate in or lead CAPA-related projects, ensuring compliance, quality, and adherence to deadlines.

• Compile, analyze, and report performance metrics related to CAPAs, Change Controls, and other Quality System activities.

• Support continuous improvement initiatives within the Quality Management System.

• Manage and maintain document control processes within the eQMS.

• Support the issuance, revision, and periodic review of Standard Operating Procedures (SOPs), ensuring alignment with regulatory and corporate standards.

• Ensure procedural workflows are up to date and compliant with GMP requirements.

• Administer and monitor Quality Agreements with external partners, ensuring alignment with regulatory and corporate standards.

• Support external audits by providing documentation, data analysis, and process insights as required.

Who You Are

• Degree in Life Sciences, Pharmacy, Chemistry, or a related scientific discipline.

• At least 3 years of experience in Quality Assurance or Quality Compliance within the pharmaceutical industry.

• Strong knowledge of GMP requirements and regulatory expectations.

• Experience working with electronic Quality Management Systems (eQMS).

• Solid understanding of SOP management, Quality Agreements, and CAPA processes.

• Strong organizational skills, attention to detail, and ability to manage multiple priorities.

• Excellent communication skills and ability to work effectively in a cross-functional environment.

• Good command of English, both written and spoken.

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.