NPI Quality Compliance Specialist (Biologics)
Department:
Quality Assurance
Location
: Sligo
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 contract 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 By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.