AbbVie is a global pharmaceutical leader discovering innovative medicines that solve serious health challenges in immunology, oncology, neuroscience, and eye care. Join our team in Manorhamilton, Sligo, and make a remarkable impact on people’s lives while advancing your career in pharmaceutical compliance.
About the Role
We are seeking an experienced NPI Compliance Specialist to join our team in Sligo on a fixed-term contract. You’ll ensure new products transferred to AbbVie Sligo meet all regulatory requirements and company standards, playing a crucial role in bringing life-changing medicines to patients worldwide.
Key Responsibilities
- Maintain effectiveness of new product integration into AbbVie’s NPI quality system
- Ensure new products manufactured at AbbVie Ireland comply with regulatory requirements and company policies
- Support new product transfers from development through commercialization stages
- Coordinate vendor evaluation, approval, and management of technical agreements
- Review and approve NPI-related analytical test method transfers and validations
- Collaborate with CMC QA, R&D, S&T, and cross-functional teams on quality compliance
- Coordinate site reviews of product specification documents including API, drug product, and raw material specifications
- Manage new product exception documentation and corrective/preventative actions
- Generate product transfer documentation for stage gate reviews
- Interface with internal auditors and regulatory agencies as subject matter expert
- Adhere to all EHS & E standards, procedures, and policies
Required Qualifications
Essential Requirements
- Third-level qualification in science or quality discipline
- Minimum 3 years’ experience in pharmaceutical or sterile manufacturing environment
- Strong written and verbal communication skills
- Demonstrated strong work ethic and attention to detail
Preferred Qualifications
- Experience with regulatory compliance in pharmaceutical manufacturing
- Knowledge of analytical method transfer and validation processes
- Experience working with cross-functional teams in pharmaceutical environment
- Understanding of pharmaceutical quality systems and documentation
What We Offer
- Competitive salary and comprehensive benefits package
- Opportunity to work with cutting-edge pharmaceutical technologies
- Career development and advancement opportunities within a global organization
- Collaborative work environment with cross-functional teams
- Chance to make a meaningful impact on patient lives worldwide
- Fixed-term contract with potential for career progression
Ready to Apply?
Take the next step in your pharmaceutical compliance career with AbbVie. Join our mission to discover and deliver innovative medicines that transform lives. This is more than a job – it’s an opportunity to make a real difference in global healthcare.
