Remote Quality Compliance & Supplier Systems Lead

KCR Placement; Warszawa; Hybrid; PLN 353,000 - 509,000; Full time

Benefits offered by this job

Health insurance

Retirement planning

Employee Assistance Program (LifeWorks

Life assurance

Flexible country‑specific benefits

Job summary

ICON Strategic Solutions seeks an Audit Operational Specialist to support supplier quality activities and ensure GMP compliance within a sponsor‑dedicated model. You will work with global teams to maintain quality records and drive continuous improvement across QA processes.

Minimum 5+ years in healthcare or related fields with GMP experience, plus strong project management and risk‑assessment skills. Remote work options are available under global programs.

Qualifications

• Bachelor's degree in Life Sciences, Regulatory Affairs, or Compliance.
• Working knowledge of current GMP requirements for biopharma/medical device industries.
• Experience in supplier quality management and auditing GMP suppliers (e.g., CMOs).
• Experience with risk management strategies and general project management.
• Proven success in continuous improvement initiatives and cross‑functional collaboration.

Responsibilities

• Quality assurance support for supplier quality management and compliance.
• Manage SNCs, support NSRs and supplier audits; ensure quality records are inspection‑ready.
• Identify and mitigate risks; monitor key quality metrics.
• Perform Medical Device Batch Release activities.
• Support GMP audits and supplier identification/selection processes.

Skills

Supplier QA

Audit management

Risk management

Project management

GMP knowledge

Education

Bachelor's degree in Life Sciences, Regulatory Affairs, or Compliance

Job description

ICON Strategic Solutions seeks an Audit Operational Specialist to support supplier quality activities and ensure GMP compliance within a sponsor‑dedicated model. You will work with global teams to maintain quality records and drive continuous improvement across QA processes.

Minimum 5+ years in healthcare or related fields with GMP experience, plus strong project management and risk‑assessment skills. Remote work options are available under global programs.