Center Quality Leader — Compliance & Donor Safety

Octapharma Plasma

Albuquerque (NM)

On-site

USD 70,000 - 100,000

Full time

14 days+
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Benefits offered by this job

401(k)
Health insurance
HSA
FSA
Tuition reimbursement
EAP
Wellness program
PTO
Personal time off
Disability insurance
Life insurance

Job summary

Octapharma Plasma is seeking a Center Quality Manager I to ensure regulatory compliance across plasma collection operations and to oversee quality control, donor safety, and documentation. You will lead QA activities, coordinate audits, and drive continuous improvement.

Requirements include a B.S. degree and a minimum of 1 year in QA, with strong knowledge of FDA/EMA standards and experience with QMS. This full-time role emphasizes cross-functional leadership and adherence to SOPs.

Qualifications

  • B.S. degree or higher; other education/experience combinations may be considered.
  • 1 year of experience in a Quality Assurance role required.
  • Knowledge of FDA, EMA, ISO and other regulatory standards applicable to plasma collection and handling.

Responsibilities

  • Operate independently of plasma center Operations to ensure regulatory compliance.
  • Report critical incidents and negative trends to Operations team and Regional QA Director.
  • Collaborate with Operations to ensure product quality and donor safety.
  • Oversee QC processes including donor screening, plasma collection, storage, and shipping.
  • Lead internal/external audits and inspections; prepare for them and communicate outcomes.
  • Perform root cause analysis and implement corrective/preventive actions.
  • Lead monthly QA meetings; manage SOP changes and regulatory requirements.

Skills

Quality Assurance leadership
Regulatory knowledge (FDA/EMA)
Quality management systems
Documentation & audits
Analytical problem solving

Education

Bachelor's degree in a related field

Tools

QMS software

Job description

Octapharma Plasma is seeking a Center Quality Manager I to ensure regulatory compliance across plasma collection operations and to oversee quality control, donor safety, and documentation. You will lead QA activities, coordinate audits, and drive continuous improvement.

Requirements include a B.S. degree and a minimum of 1 year in QA, with strong knowledge of FDA/EMA standards and experience with QMS. This full-time role emphasizes cross-functional leadership and adherence to SOPs.

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