Head Of Program Quality, Spc

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn.

We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.

At Recordati, our mantra is simple. We\'ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.

This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.

Recordati. Unlocking the full potential of life.

Job Purpose

Responsible for developing and leading the global QA strategy and operations for the SPC Business Unit (current and upcoming products). This role ensures that all products meet regulatory requirements, corporate quality standards, and industry best practices, acting as the quality steward across the entire portfolio. He / She will collaborate internally cross-functionally with R&D, Regulatory Affairs, Manufacturing, and Commercial teams and externally CMOs to support the company\'s commitment to delivering safe and effective therapies to patients. This is a global leadership role with oversight of teams across multiple geographies.

Key Responsibilities

QA Strategy

• Develop the QA SPC products strategy across clinical, manufacturing and commercial product lifecycle
• Ensure end-to-end quality oversight and implementation of the quality system

Process Compliance

• Ensure adherence to international standards and internal SOPs across all QA- SPC related processes
• Promote a culture of compliance by embedding quality principles into day-to- day operations, proactively identifying process gaps, and leading cross- functional remediation efforts
• Enhance process robustness across clinical, manufacturing, and distribution activities to minimize compliance risks and Regulatory Compliance

Manufacturing Quality

• Partner with internal and external manufacturing partners (CMOs) to ensure product quality, batch release and deviation Management

Management of Health Authority inspections

• Act as primary QA liaison with regulatory authorities, leading the preparation for inspections, hosting audits, and managing follow-up actions with a strategic mindset. This includes :
• Ensuring robust documentation practices and data integrity
• Overseeing the preparation and quality review of regulatory submissions, ensuring that quality components reflect sound science, risk based thinking, and transparent justification of decisions
• This role must anticipate regulator concerns not only regarding product safety and efficacy but also manufacturing scalability, cold chain integrity, product traceability, and long-term follow-up

QA GMP

• Coordinate GMP within CMOs and act as a main point of contact

QA GDP

• Coordinate activities of QA functions of SPC commercial affiliates to ensure they operate in compliance with applicable GDP

Strategic Relationship and Quality Integration

• Act as the primary Quality point of contact for strategic business directions in partnership with Commercial, Regulatory Affairs, Product Supply and BD

Serves as primary Quality point of contact for :

product Technical