Senior QA Lead - GCP & PV (Biotech, Remote)

Akero Therapeutics; Remote; PLN 592,000 - 629,000; Full time

Job summary

A clinical stage biopharmaceutical company in Poland is seeking an Associate Director of Quality Assurance to lead quality oversight for clinical development and pharmacovigilance activities. The role requires ensuring compliance with GCP and GVP standards while collaborating with various departments. The ideal candidate will have at least 10 years of experience in quality assurance, strong communication skills, and a background in life sciences or biotechnology. The compensation range for this position is $165,000 - $175,000 per annum.

Qualifications

• Minimum of 10 years of experience in Quality Assurance within Clinical Operations and/or Pharmacovigilance.
• Strong knowledge of global regulatory requirements: ICH-GCP, FDA GCP regulations, and international GVP standards.
• Experience with CRO and PV vendor oversight, including audits and inspections.

Responsibilities

• Provide QA oversight for clinical trials for biologic programs.
• Ensure compliance with ICH-GCP and FDA regulations.
• Monitor compliance with global GVP requirements.

Skills

Quality Assurance

Regulatory Compliance

Communication Skills

Organizational Skills

Collaboration

Education

Bachelor’s or advanced degree in Life Sciences, Biotechnology, Pharmacy

Tools

EDC

CTMS

Argus

ARISg

Veeva Vault

Job description

A clinical stage biopharmaceutical company in Poland is seeking an Associate Director of Quality Assurance to lead quality oversight for clinical development and pharmacovigilance activities. The role requires ensuring compliance with GCP and GVP standards while collaborating with various departments. The ideal candidate will have at least 10 years of experience in quality assurance, strong communication skills, and a background in life sciences or biotechnology. The compensation range for this position is $165,000 - $175,000 per annum.