Senior Specialist, QA External Manufacturing

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 Senior QA Specialist – External Manufacturing is responsible for ensuring quality and compliance of pharmaceutical and Consumer Healthcare (CHC) products manufactured at Contract Manufacturing Organizations (CMOs). The role combines hands-on Quality Assurance activities with advanced oversight of investigations, risk assessments, and change controls.

This position acts as a key quality contact for assigned external sites, contributing to supplier governance, continuous improvement initiatives, and product lifecycle management, while ensuring compliance with GMP, GDP, ICH guidelines, and internal company standards.

Your Role

In this role, you will:

Serve as the primary QA contact for assigned CMOs, monitoring performance through quality metrics, documentation review, and regular governance meetings.
Support batch review and release activities, ensuring thorough evaluation of manufacturing and packaging records, analytical results, deviations, and associated changes.
Review and manage deviations, investigations (including OOS/OOT), and CAPAs, ensuring scientific soundness, robustness, and timely closure.
Assess change controls from CMOs, collaborating with cross-functional teams (Regulatory, MS&T, Supply Chain, Procurement) to ensure compliant implementation.
Participate in internal audits, CMO audits, and regulatory inspection readiness activities, following up on corrective actions.
Maintain and update Quality Agreements to reflect current operations and compliance requirements.
Drive continuous improvement initiatives related to quality systems and external manufacturing performance.
Support technology transfers, scale-ups, and new product introductions from a QA perspective.
Partner with Technical Operations and MS&T to enhance processes and product quality.

Who You Are

The ideal candidate has:

A Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, Engineering, or a related field.
3–5+ years of experience in a GMP Quality Assurance role within the pharmaceutical or CHC industry.
Experience in external manufacturing or supplier quality (strongly preferred).
Solid knowledge of EU/FDA GMP regulations, ICH guidelines, and quality management systems.
Strong ability to review complex documentation with accuracy and attention to detail.
Problem-solving skills with experience in root cause analysis.
Excellent communication skills to effectively interface with internal stakeholders and external partners.
Ability to manage multiple priorities and work independently with moderate supervision.
Familiarity with digital quality tools and AI applications.
Proficiency in English; additional languages are a plus.

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.