About the Role
We are seeking an experienced QC Pharmaceutical Laboratory Manager to lead and oversee the Westport-based testing schedule for raw materials, stability studies, in-process materials, and final commercial release products.
This role is responsible for ensuring that testing activities are completed in accordance with Good Manufacturing Practice (GMP), AbbVie Worldwide Quality Assurance (WWQA) standards, and applicable regulatory requirements, including those of the FDA, EMA, HPRA, and other health authorities.
The successful candidate will be an active and visible leader within the laboratory, engaging and motivating team members, constructively challenging performance, and creating opportunities for professional growth and development.
Key Responsibilities
People Leadership
- Lead, motivate, and develop team members, taking appropriate action to address individual performance when required.
- Conduct performance and development meetings in line with company policies and procedures.
- Participate actively in the recruitment and selection of laboratory team members.
- Monitor attendance and timekeeping and take appropriate action where standards are not met.
- Support the training, qualification, and certification of new employees.
- Ensure the area is appropriately staffed and that resource constraints are effectively managed.
- Promote a culture in which all activities are completed in compliance with AbbVie and regulatory requirements.
Operational and Strategic Support
- Provide testing completion dates to support raw material, stability, in-process, and final commercial release timelines.
- Monitor team performance and provide relevant KPI data.
- Lead Tier 2 meetings and support effective escalation and issue resolution.
- Represent QC Pharma at meetings and forums as directed by senior management.
- Coordinate the review and approval of local and global quality documents.
- Ensure team activities support AbbVie’s strategic objectives, including effective collaboration across functions and business units.
Departmental Support and Compliance
- Collaborate with laboratory management colleagues to ensure testing is completed, reviewed, validated, and released in line with procedural timelines and site and laboratory performance targets.
- Facilitate resource allocation across QC Pharma teams to support business priorities, meet testing timelines, and provide professional development opportunities.
- Coordinate with laboratory management and laboratory trainers to ensure appropriate cross-training is completed.
- Maintain inspection readiness for internal and external audits and regulatory inspections.
- Support continuous improvement initiatives across the laboratory.