NPI QA Specialist - 12 month FTC

AbbVie; Dublin; On-site; EUR 70,000 - 90,000; Full time

Job summary

AbbVie in Dublin seeks a Senior NPI Compliance Specialist to lead the integration of projects into the AbbVie quality system and ensure regulatory alignment for North Dublin site transfers from development through commercialization.

You will collaborate with local and cross-functional teams to address quality concerns, support analytical method transfers, and drive corrective actions to prevent recurrence. Experience in pharmaceutical quality roles and QP eligibility are valued.

Qualifications

• Third level qualification in a science discipline.
• 5 years’ experience in the healthcare / pharmaceutical industry.
• A minimum of 3 years experience in a Quality role.
• Being QP eligible is desirable.

Responsibilities

• Responsible for implementing and maintaining the effectiveness of the integration of projects and NPI into the AbbVie quality system.
• Ensuring projects at AbbVie North Dublin meet the requirements of applicable regulatory requirements and AbbVie procedures and policies.
• Senior NPI Compliance Specialist is responsible for supporting new product transfers to the site from development through commercialization, liaising closely with local and external cross functional teams to provide direction on quality concern and ensure appropriate mitigation to address potential risk.
• Support review and approval of NPI related Analytical Test Method Transfers and/or validation.
• Support vendor evaluation and approval, management of all technical agreements from initiation review, approval and storage.
• Collaborate with local and above site functional groups to maintain roles and responsibilities, identify potential quality issues, obtain an understating of the quality compliance and provide input on quality concerns.
• Coordination of site review of new product related material specification documents including but not limited to, intermediate specifications, API specifications, Drug product specifications, raw material specifications and excipient specifications.
• Support the management of new project related exception documentation including the generation of corrective and preventative action to prevent reoccurrence.
• Generation of quality project documentation to attest the completion of project transfer deliverables, in advance of the applicable project stage review.
• Interfaces with internal and external stakeholders as the Quality subject matter expert for new projects / NPIs.
• Responsible for the coordination of Management review and presentation to site management team as directed.
• Responsible for the coordination of site QA Metrics as required.
• QA supports Market Expansions as associated change controls regarding assessment on behalf of the site and approval as such.
• Support QA specialist team when required to meet site compliance.
• Lead and Support Site Quality projects and drive to completion and due date.
• Track and trend of quality projects on site to management .
• Support onsite internal and external audits as required.

Skills

Quality systems

Regulatory compliance

NPI transfers

Vendor management

Cross-functional collaboration

Education

Science degree

Tools

Regulatory databases

Job description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Primary duties and responsibilities of the position are as follows, other duties may be assigned:

• Responsible for implementing and maintaining the effectiveness of the integration of projects and NPI into the AbbVie quality system.
• Ensuring projects at AbbVie North Dublin meet the requirements of applicable regulatory requirements and AbbVie procedures and policies.
• Senior NPI Compliance Specialist is responsible for supporting new product transfers to the site from development through commercialization, liaising closely with local and external cross functional teams to provide direction on quality concern and ensure appropriate mitigation to address potential risk.
• Support review and approval of NPI related Analytical Test Method Transfers and/or validation.
• Support vendor evaluation and approval, management of all technical agreements from initiation review, approval and storage.
• Collaborate with local and above site functional groups to maintain roles and responsibilities, identify potential quality issues, obtain an understating of the quality compliance and provide input on quality concerns.
• Coordination of site review of new product related material specification documents including but not limited to, intermediate specifications, API specifications, Drug product specifications, raw material specifications and excipient specifications.
• Support the management of new project related exception documentation including the generation of corrective and preventative action to prevent reoccurrence.
• Generation of quality project documentation to attest the completion of project transfer deliverables, in advance of the applicable project stage review.
• Interfaces with internal and external stakeholders as the Quality subject matter expert for new projects / NPIs.
• Responsible for the coordination of Management review and presentation to site management team as directed.
• Responsible for the coordination of site QA Metrics as required.
• QA supports Market Expansions as associated change controls regarding assessment on behalf of the site and approval as such.
• Support QA specialist team when required to meet site compliance.
• Lead and Support Site Quality projects and drive to completion and due date.
• Track and trend of quality projects on site to management .
• Support onsite internal and external audits as required.

Qualifications

• Third level qualification in a science discipline.
• 5 years’ experience in the healthcare / pharmaceutical industry.
• A minimum of 3 years experience in a Quality role.
• Being QP eligible is desirable.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html