QA Manager, GMP & Training Excellence

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

Benefits offered by this job

Competitive salary and incentives

Health coverage (medical, dental, and视

Retirement savings with employer match

Paid time off

Professional development opportunities

Employee wellness programs

Job summary

Bora Bora Pharmaceuticals seeks a seasoned Quality Assurance leader to oversee GMP QA for commercial manufacturing and packaging. You will supervise QA staff, manage batch records, deviations, CAPA, and complaints while ensuring compliance with FDA requirements.

You will own the training system, govern curricula, monitor qualifications, and coordinate with operations and quality teams to sustain product quality across transitions to steady-state operations.

Qualifications

• Bachelor's degree (BA/BS) in life sciences or engineering.
• 8+ years of Quality Assurance experience in pharmaceutical or medical device industries.
• 2+ years of leadership or supervisory experience.
• Strong knowledge of cGMP regulations and FDA inspection expectations.
• Excellent verbal and written communication for cross-functional stakeholders.

Responsibilities

• Provide direct QA oversight for commercial manufacturing and packaging operations.
• Review and approve batch records, logbooks, procedures and GMP documentation.
• Manage deviation records, investigations, CAPA, and complaint support.
• Own site GMP training system, curriculum governance, LMS administration, and training metrics.
• Collaborate with Operations,Quality Control, Engineering, and Client & Project Quality to ensure compliance.

Skills

Leadership

Quality Assurance

Regulatory compliance

Analytical thinking

Problem solving

Communication skills

Education

BA/BS in life sciences or engineering

Tools

TrackWise

Veeva Vault

Job description

Bora Bora Pharmaceuticals seeks a seasoned Quality Assurance leader to oversee GMP QA for commercial manufacturing and packaging. You will supervise QA staff, manage batch records, deviations, CAPA, and complaints while ensuring compliance with FDA requirements.

You will own the training system, govern curricula, monitor qualifications, and coordinate with operations and quality teams to sustain product quality across transitions to steady-state operations.