QA Manager, Technical Services & QC Lab Excellence

Allergan; Barceloneta (PR); On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie seeks a Quality Control leader to supervise the QC laboratory and ensure QA/QC compliance across the manufacturing site in Puerto Rico and the surrounding region. The role serves as a key backup to the QA Site Director and works within the site leadership to uphold quality standards.

You will lead the QC team, drive CAPA and validation efforts, review materials, and participate in regulatory inspections and audits, while managing change control and quality metrics across site operations.

Qualifications

• Bachelor’s degree with 10 years of pharmaceutical Quality experience (preferably in QC).
• Previous experience leading teams in highly desired.
• Strong background in Quality/ QC within the Pharmaceutical and/ or Biotechnology industry.
• Excellent oral and written communication skills required with the capability of clearly presenting and justifying quality requirements.

Responsibilities

• Manages the Quality Control (QC) laboratory including direct reports and budgetary responsibilities
• Member of the Laboratory Center of Excellence (COE)
• Serves as the standalone laboratory systems and site Maximo administrator
• Reviews and approves raw materials and commodities including ERP approval
• Exception Report (ER) investigation, writing, review, and approval including ensuring effective CAPAs
• Qualification and validation protocol writing, review, and approval
• Actively participates in Periodic Validation Reviews, Annual Product Reviews, internal audits, and process data reviews
• Provides front room and laboratory SME support during regulatory agency and internal inspections
• Manages change related to compendia, supplier/service provider notifications, material specifications, analytical test methods, test method validation, SOPs, batch records, and site service requests
• Leads the implementation of Quality-related projects including metrics

Skills

Quality Control

Leadership

Maximo admin

Regulatory audits

Education

Bachelor’s degree in Pharmaceutical/QA

Tools

Maximo

Job description

AbbVie seeks a Quality Control leader to supervise the QC laboratory and ensure QA/QC compliance across the manufacturing site in Puerto Rico and the surrounding region. The role serves as a key backup to the QA Site Director and works within the site leadership to uphold quality standards.

You will lead the QC team, drive CAPA and validation efforts, review materials, and participate in regulatory inspections and audits, while managing change control and quality metrics across site operations.