Head Of Program Quality, Spc

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 Transfer QMS integration of new products from M&A, in licensing agreements and R&D Required Education Degree in Life Sciences, Pharmacy, or a related field Required Skills and Experience Minimum 15 years of experience in the pharmaceutical / biotech industry with at least 7 years in a senior QA leadership role Demonstrated experience in rare diseases or orphan drugs, ideally in both development and commercial settings Experience managing external partners (CMOs) Working experience in international contexts, preferrable global ones Proven ability to operating in a matrix environment Technical Competencies Strategic thinking & global perspective Influencing & negotiating GMP, GCP, GDP knowledge Project management Managing People Networking and collaborating Required Behaviours and Competencies Proactivity in change Resilience and adaptability Required Languages English Travel required in % J-18808-Ljbffr J-18808-Ljbffr

Location: Lombardia, IT

Posted Date: 8/20/2025