QC Pharmaceutical Laboratory Manager

AbbVie Inc.; Missouri; Hybrid; USD 110.000 - 165.000; Vollzeit

Zusammenfassung

AbbVie in Westport, MO is seeking an experienced QC Pharmaceutical Laboratory Manager to lead the testing schedule for raw materials, stability studies, in-process materials, and final release products, ensuring GMP and WWQA compliance.

The role requires active leadership, performance management, and development of lab staff, with a strong focus on regulatory readiness and cross-functional collaboration to meet timelines and quality targets.

Qualifikationen

• Demonstrated experience in direct people management, including performance management, development planning, and conflict resolution.
• Strong knowledge of GMP standards and regulations, particularly laboratory-related requirements.
• Experience working in a pharmaceutical, biotechnology, or other regulated laboratory environment.
• Excellent written and verbal communication skills, with the ability to communicate clearly and concisely.
• Confidence communicating with external stakeholders, including regulatory inspectors and auditors.
• Strong organizational and planning skills, with the ability to manage competing priorities and meet demanding timelines.
• Demonstrated ability to work collaboratively across functions and build effective relationships.

Aufgaben

• Lead, motivate, and develop team members, addressing performance when required.
• Provide testing completion dates to support raw material, stability, in-process, and final commercial release timelines.
• Monitor KPI data and lead Tier 2 meetings.
• Coordinate review and approval of local and global quality documents.
• Maintain inspection readiness for audits and regulatory inspections.
• Support cross-training and resource allocation across QC Pharma teams.

Kenntnisse

People leadership

GMP knowledge

Regulatory communication

Cross-functional collaboration

Ausbildung

Bachelor's degree in a scientific discipline

Jobbeschreibung

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

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.

Qualifications

• Bachelor's degree or equivalent qualification in a relevant scientific discipline.
• Demonstrated experience in direct people management, including performance management, development planning, and conflict resolution.
• Strong knowledge of GMP standards and regulations, particularly laboratory-related requirements.
• Experience working in a pharmaceutical, biotechnology, or other regulated laboratory environment.
• Excellent written and verbal communication skills, with the ability to communicate clearly and concisely.
• Confidence communicating with external stakeholders, including regulatory inspectors and auditors.
• Strong organizational and planning skills, with the ability to manage competing priorities and meet demanding timelines.
• Demonstrated ability to work collaboratively across functions and build effective relationships.