Quality Manager

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

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Quality Manager

Role

Responsible person according international and local laws for maintaining a Quality System based on applicable Good Distribution Practices principles and Corporate Quality standards of medicinal products and medical devices.

Activities and responsibilities

• Be the Responsible Person as per GDP requirements.
• To assure distribution activities (procurement, storage, complaints management…), to be in compliance with Good Distribution Practices regulation.
• Elaborate, approve and keep updated relevant SOPs and records.
• Responsible for the local batch release of medicinal products and medical devices in compliance with and local requirements.
• Responsible to approve returns to saleable stock.
• Overview of GDP subcontracted activities and service providers (initial and regular requalification, audits, CAPA follow up, quality agreements, performance, etc…)
• Review of publicity messages and promotional material from a Regulatory perspective.
• Responsible and local contact for pharmacovigilance.
• To obtain and keep updated all the licenses necessary for products and/ordistribution activities.
• Regulatory Affairs local contact person with local authorities and Headquarters.
• Implementation, maintenance and continuous improvement of a quality system according to GDP regulations and Corporate Quality standards: record and coordination of complaints, deviations, CAPAs, change control, risk analysis, internal and external audits.
• Host Authorities Health inspections and internal, corporate or customer audits
• Liaison with National Regulatory Authority of the country and neighboring countries.
• Liaising with other parties including with Quality personnel at manufacturing sites, Logistics and Customer Services, headquarters, etc.
• Ensure training programmes are implemented, maintained, and effective for all relevant staff.
• Lead and coordinate recall operations
• Other applicable by local laws.

Academic requirements

Degree in Pharmacy.

Knowledge skills and abilities

• 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.

Professional Experience

• 5 years’ experience managing a Quality System in a similar position,
• Experience in GDP.
• In-depth knowledge of Polish and EU legislation applicable to medicinal products and medical devices.

Scope

Countries associated to the affiliate (Poland and other Baltic countries).

IT

• Proficient in Microsoft Office (especially Excel and Word).