Center Quality Manager: Compliance & Training Lead

Octapharma Plasma; Maplewood (MN); On-site; USD 64,000 - 107,000; Full time

Benefits offered by this job

Formal training

Health insurance

HSA

FSA

Tuition Reimbursement

EAP

Wellness program

401k retirement plan

Paid time off

Company paid holidays

Personal time

Job summary

Octapharma Plasma is seeking a Center Quality Manager I in Maplewood, MN to operate independently from plasma center Operations, ensuring compliance with FDA/EMA and other standards. You will mentor staff, oversee QA processes, and lead audits to safeguard donor safety and product quality.

The role requires a BS degree preference and at least one year in QA, with knowledge of GMP, CAPA, and QMS. Excellent collaboration with Operations is essential for continuous improvement and regulatory

Qualifications

• BS degree preferred.
• 1 year of experience in a Quality Assurance role required.
• Experience with quality management systems (QMS) and quality control processes preferred.

Responsibilities

• Operate independent of plasma center Operations to ensure compliance with all applicable regulations and standards.
• Maintain current knowledge of regulations and standards affecting plasma collection and donor safety.
• Prepare for and lead internal and external audits and inspections.
• Develop and implement audit responses ensuring timely completion and adherence to quality standards.
• Provide direction and oversight of Quality Back-up staff and ensure quality tasks are completed within time frames.
• Perform other duties as assigned.

Skills

Quality Assurance

Regulatory compliance

GMP knowledge

CAPA

Audits

Quality systems

Education

BS degree preferred

Tools

QMS software

Job description

Octapharma Plasma is seeking a Center Quality Manager I in Maplewood, MN to operate independently from plasma center Operations, ensuring compliance with FDA/EMA and other standards. You will mentor staff, oversee QA processes, and lead audits to safeguard donor safety and product quality.

The role requires a BS degree preference and at least one year in QA, with knowledge of GMP, CAPA, and QMS. Excellent collaboration with Operations is essential for continuous improvement and regulatory