QA Lead, Global Pharma Ops & Training

Bora Pharmaceuticals; Maple Grove (MN); On-site; USD 108,000 - 150,000; Full time

Job summary

Bora Pharmaceuticals in Minnesota seeks an experienced Quality Assurance leader to oversee routine commercial QA activities, batch-record review, CAPA execution, complaint support, and product disposition. You will lead the Training team and own the site GMP training system, ensuring compliance across operations and regulatory readiness.

You will collaborate with Operations, Technical Services, Quality Control, Engineering, and Client & Project Quality to drive continuous improvement, training

Qualifications

• Bachelor's degree in life sciences, chemistry, biology, or engineering.
• 8+ years of Quality Assurance experience in pharma/medical device.
• 2+ years of leadership or supervisory experience.
• Strong knowledge of cGMP, 21 CFR Parts 210/211, and FDA expectations.
• Excellent verbal and written communication, leadership, and collaboration.

Responsibilities

• Provide direct QA oversight for commercial manufacturing and packaging.
• Lead batch-record review, deviation/CAPA execution, complaint support, and product disposition.
• Oversee training systems, curriculum governance, LMS administration, and training metrics.
• Coordinate with Operations, Technical Services, Quality Control, Engineering, and Client & Project Quality.
• Support customer and regulatory audits with QA processes and records.

Skills

QA Leadership

GMP Compliance

Regulatory Audits

Training & Development

Education

Bachelor's degree in life sciences or engineering

Tools

TrackWise

Veeva Vault

Job description

Bora Pharmaceuticals in Minnesota seeks an experienced Quality Assurance leader to oversee routine commercial QA activities, batch-record review, CAPA execution, complaint support, and product disposition. You will lead the Training team and own the site GMP training system, ensuring compliance across operations and regulatory readiness.

You will collaborate with Operations, Technical Services, Quality Control, Engineering, and Client & Project Quality to drive continuous improvement, training