NPI Compliance Specialist (Biologics)

NPI Compliance Specialist (Biologics) Department: Quality Assurance
Reporting to: NPI Compliance Manager

We are currently recruiting for an experienced NPI Compliance Specialist (Biologics) to support the successful transfer and commercialization of new biologic products at a regulated manufacturing site. This role plays a critical part in ensuring new products are integrated into the site Quality Management System in full compliance with regulatory and company requirements.

Key Responsibilities

• Ensure new products transferred to the site are manufactured in compliance with applicable regulatory requirements, internal policies, and quality standards.
• Maintain the effectiveness of quality system integration for all new product introductions.
• Support new product transfers from development through commercialization, working closely with internal and external cross-functional teams to identify and mitigate quality risks.
• Provide quality direction and subject matter expertise throughout technology and product transfer activities.
• Support vendor evaluation and approval processes, including the initiation, review, approval, and maintenance of technical agreements.
• Review and approve NPI-related analytical test method transfers and/or validation activities.
• Coordinate site review of new product-related material specifications, including raw materials, excipients, in-process, BDS, and drug product specifications.
• Support the management of new product-related exceptions, including the development of corrective and preventative actions (CAPAs).
• Generate and maintain product transfer documentation to support stage gate reviews and commercialization readiness.
• Act as the quality subject matter expert during internal audits and external regulatory inspections related to new products and technology transfers.
• Collaborate closely with QA, CMC, R&D, Science & Technology, and other functional groups to ensure clarity of roles, responsibilities, and compliance expectations.
• Adhere to and actively support all EHS and environmental standards, procedures, and policies.

Requirements

• Third-level qualification in Science, Quality, Engineering, or a related discipline.
• Minimum of 3 years’ experience in a quality role supporting New Product Introduction (NPI) within a regulated pharmaceutical or biologics environment.
• Strong working knowledge of regulatory requirements (GMP, quality systems, and compliance expectations).
• Experience supporting product or technology transfers from development through commercialization.
• Excellent cross-functional communication and stakeholder management skills.

Desirable

• Experience working in an aseptic manufacturing or biologics environment.
• Prior quality experience supporting analytical method transfer and validation activities.

For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.