Director, Clinical and Safety Quality

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.

Purpose of the Job

The Clinical & Safety Quality Director is responsible for establishing, leading, and maintaining an effective Clinical and Pharmacovigilance Quality Management System (QMS) to ensure GCP and GVP compliance for all sponsored clinical development activities and commercial products.

The role provides strategic quality oversight of clinical trials and safety activities across a development portfolio mainly spanning Phase II to Phase IV, ensuring inspection readiness and continuous improvement while enabling timely and compliant execution of clinical programs.

Principal Accountabilities

• Define, implement, and maintain the Clinical and Safety Quality strategy aligned with global regulatory requirements (ICH-GCP, EU CTR, GVP Modules, FDA regulations).
• Ensure effective oversight of Sponsor responsibilities for outsourced clinical and pharmacovigilance activities conducted by CROs, vendors, and partners.
• Lead the development, maintenance, and continuous improvement of Clinical and PV Quality Management Systems, including SOPs, standards, and governance processes.
• Plan and execute quality oversight activities, including:
• Clinical and PV audits (internal, vendor, affiliates, system, and study audits)
• Quality risk assessments
• Vendor qualification and performance monitoring
• Ensure inspection readiness and act as quality lead during regulatory inspections (EMA, FDA, MHRA, PMDA) related to clinical and safety activities.
• Oversee CAPA management, deviation handling, and root cause analysis related to clinical and safety quality issues.
• Provide quality input and decision support to clinical development teams, pharmacovigilance, regulatory affairs, and senior management.
• Promote a quality culture across clinical and safety organizations, supporting training, coaching, and awareness initiatives.
• Monitor regulatory intelligence and proactively adapt quality processes to evolving requirements (e.g. EU CTR, ICH E6(R3), digital trials).
• Contribute to portfolio and program governance committees as quality subject matter expert.

Requirements 

• Minimum 10–12 years of experience in pharmaceutical or biotech environments.
• At least 5 years in Clinical Quality Assurance and/or Pharmacovigilance Quality roles.
• Direct experience supporting Phase II–IV clinical development programs.
• Hands-on experience with regulatory inspections and health authority interactions.
• Experience in global or multi regional clinical development organizations is strongly preferred.
• Strong expertise in ICH-GCP and GVP requirements applicable to Sponsors.
• Demonstrated experience in clinical and/or pharmacovigilance quality oversight in a pharmaceutical company environment.
• Solid knowledge of outsourced clinical development models and CRO/vendor oversight.
• Proven ability to lead inspections, audits, and complex quality issue resolution.
• Strategic mindset with the ability to balance compliance, risk management, and operational agility.
• University degree in Life Sciences, Pharmacy, Medicine, Biology, Chemistry, or related discipline.
• Advanced degree (PhD, PharmD, MD) is an advantage.
• Leadership and influencing skills in matrix and cross functional environments.
• Strong analytical and risk-based decision making capabilities.
• Excellent communication skills, both written and verbal, in English.
• Ability to translate regulatory requirements into pragmatic, business focused quality solutions.
• Change leadership and continuous improvement mindset.
• High integrity, independence, and accountability

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.