GDP Quality Manager – Regulatory, Audits & Recalls Lead

Grifols, S.A; Warszawa; On-site; PLN 240,000 - 380,000; Full time

Job summary

Grifols, S.A. is seeking a Quality Manager in Poland to lead the quality system under GDP and corporate standards. You will ensure compliant distribution activities, develop and maintain SOPs, and act as the Responsible Person for GDP. The role also covers regulatory liaison, audits, and recalls where needed.

The position requires a Pharmacy degree, strong organizational and analytical skills, and experience with GDP and European Medicines Agency expectations. Based in Poland with regional scope.

Qualifications

• Strong resourcefulness and ability to proactively seek information, engage with stakeholders and independently resolve issues.
• Excellent organizational skills.
• Excellent attention to detail.
• Team Player and strong interpersonal skills.

Responsibilities

• Be the Responsible Person as per GDP requirements.
• Assure distribution activities are compliant with GDP and corporate standards.
• Elaborate, approve and maintain relevant SOPs and records.
• Local batch release of medicinal products and medical devices.
• Approve returns to saleable stock and oversee GDP subcontracted activities.
• Review publicity messages from a Regulatory perspective.
• Be the local pharmacovigilance contact and obtain necessary licenses.
• Coordinate training, inspections, audits and regulatory liaison.

Skills

Resourceful

Organizational skills

Attention to detail

Team player

Education

Degree in Pharmacy

Tools

Microsoft Office

Job description

Grifols, S.A. is seeking a Quality Manager in Poland to lead the quality system under GDP and corporate standards. You will ensure compliant distribution activities, develop and maintain SOPs, and act as the Responsible Person for GDP. The role also covers regulatory liaison, audits, and recalls where needed.

The position requires a Pharmacy degree, strong organizational and analytical skills, and experience with GDP and European Medicines Agency expectations. Based in Poland with regional scope.