NPI Compliance Specialist (Biologics) Department: Quality Assurance Reports to: NPI Compliance Manager Role Overview The NPI Compliance Specialist is responsible for ensuring that new products are introduced and manufactured in full compliance with regulatory requirements and internal quality systems. This role supports product transfers from development through to commercialization, ensuring quality risks are identified, assessed, and mitigated effectively. Key Responsibilities Ensure new products are transferred and manufactured in accordance with applicable regulatory requirements and internal policies. Maintain the effectiveness of integrating new products into the sites NPI quality system. Support new product introductions from development through commercialization, working closely with cross-functional teams to address quality concerns and mitigate risks. Support vendor evaluation and approval processes, including the management of technical agreements from initiation through approval and archiving. Review and approve analytical test method transfers and validation activities related to new products. Collaborate with Quality, R&D, Supply Chain, and other functional teams to ensure clarity of roles, identify potential quality risks, and provide input on compliance matters. Coordinate site review of material specification documents (e.g. in-process materials, drug substances, drug products, raw materials, and excipients). Support the management of deviations and exception documentation, including CAPA generation and follow-up. Prepare and compile product transfer documentation to support stage gate approvals. Act as a subject matter expert during internal and external audits related to new products and technology transfers. Ensure adherence to Environmental, Health & Safety (EHS) standards and procedures at all times. Requirements Third-level qualification in Science, Quality, or a related discipline. Minimum of 3 years experience in a quality role supporting new product introductions. Strong knowledge of regulatory requirements and quality systems. Experience in regulatory compliance, quality assurance, and NPI processes. Desirable: Experience in aseptic processing environments, ideally within a quality function. Core Competencies Cognitive Skills Strong understanding of regulatory and compliance requirements Excellent attention to detail and commitment to quality standards Effective decision-making and problem-solving skills Experience working within cross-functional teams Ownership & Accountability Ability to work independently with a high level of initiative Strong focus on delivering results and closing out actions Commitment to Right First Time principles Ensures compliance with cGMP and regulatory standards (e.g. HPRA, FDA) Influence & Leadership Provides guidance to cross-functional teams and external suppliers Supports continuous improvement initiatives Collaborates effectively with stakeholders across multiple functions Decision Making & Impact Makes quality-related decisions within defined quality systems and regulatory frameworks Manages day-to-day quality issues independently, escalating when necessary Contributes to maintaining compliance and product quality standards Working Relationships Works closely with internal teams across Quality, Operations, R&D, and Supply Chain Interfaces with external vendors and regulatory auditors Engages with personnel at all levels across the organization EHS Responsibilities Follow all EHS policies and procedures Maintain awareness of personal and team safety at all times Report incidents, near misses, and unsafe conditions promptly Participate in EHS training and improvement initiatives Use appropriate PPE as required