Senior QA Manager — Manufacturing Quality & Training

Bora Pharmaceuticals; Maple Grove (MN); In loco; USD 120.000 - 160.000; Tempo pieno

Descrizione del lavoro

Bora Pharmaceuticals, a premier CDMO, seeks a senior QA leader to oversee commercial manufacturing quality, CAPA, batch review, and training programs. You will drive GMP compliance, partner across Operations, Quality Control, and Engineering, and mentor a team of QA specialists and training professionals.

Engineering a robust quality system, you will own training governance, metrics, and inspection readiness, ensuring seamless transition of products from project mode to steady-state operations

Competenze

• Bachelor's degree in life sciences (chemistry, biology) or engineering.
• Minimum of 8 years of Quality Assurance experience in pharmaceutical or medical device industries.
• Minimum of 2 years of leadership or supervisory experience.
• Broad knowledge of manufacturing/packaging QA, batch-record review, deviation/CAPA, complaint investigations, product disposition, GMP training systems.

Mansioni

• Provides direct supervision, performance management, coaching, resource planning, scheduling, workload prioritization, and professional development for QA staff.
• Provides daily QA support and shop-floor/operational QA coverage for commercial manufacturing and packaging activities.
• Oversees review and approval of batch records, logbooks, procedures, and GMP documents.
• Manages deviation records, investigations, root-cause analysis, and CAPA execution.
• Reviews CAPAs, ensures follow-up with evidence and action.
• Owns final product disposition for routine commercial products after validation of quality records.
• Supports audits by presenting QA processes, training controls, and records.
• Drives continuous improvement in QA coverage, batch review, investigations, and training processes.

Conoscenze

Leadership

Quality assurance leadership

Regulatory compliance

Cross-functional collaboration

Verbal & written communication

Problem solving

Formazione

Bachelor's degree in life sciences or engineering

Strumenti

TrackWise

Veeva Vault

Descrizione del lavoro

Bora Pharmaceuticals, a premier CDMO, seeks a senior QA leader to oversee commercial manufacturing quality, CAPA, batch review, and training programs. You will drive GMP compliance, partner across Operations, Quality Control, and Engineering, and mentor a team of QA specialists and training professionals.

Engineering a robust quality system, you will own training governance, metrics, and inspection readiness, ensuring seamless transition of products from project mode to steady-state operations