Group Quality Compliance Manager at Polpharma Biologics

Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!

Your responsibilities include, but are not limited to:

• Developing short-term, mid-term and long-term improvement programs to ensure and maintain compliance with current health authority requirements;
• Ensuring compliance with international (US FDA, EMA, MHRA, TGA) and national (Polish, Dutch) laws and regulations;
• Works with the sites to roll out industry best practices (e.g. ISPE, PDA, etc.);
• More specifically supports authority inspections and clients’ audits. as part of GQC;
• Coordinating site developed auditing programs for suppliers (materials) and third-party contractors (services);
• Undertaking / supporting GQC site audits / mock inspections and undertakes audits of site suppliers and third party contractors, as required;
• Developing a system for monitoring the adequacy and execution of Group Quality Compliance inspection readiness remediation actions;
• Managing the group escalation process for critical or major compliance discrepancies at sites and critical to product quality events;
• Monitoring regulatory updates and action taken by regulatory authorities and communication them with the wider Polpharma Biologics organization;
• Supporting site implemented compliance with quality system(s) and SOPs implemented;
• Helping to develop and roll out group level quality procedures, guidance documents and policies as required;
• Serving as a support to the Employees directly responsible for compliance and inspection readiness at the sites;
• Working closely with other departments to improve and simplify Polpharma Biologics quality systems and SOPs, making it easier to comply with these requirements.

If you have:

• Degree in Science, Biotechnology or a related discipline;
• Minimum 7 years in the biopharma / pharma sector. Preferably biologics experience, as distinct to pharma);
• CGMP experience obtained in (order of preference) Compliance / QA / Manufacturing;
• Experience of regulatory inspections;
• Auditing experience, as Lead Auditor;
• Passionate about CGMP & Compliance;
• Good organisational skills; 
• Ability to work across multiple sites;
• Capable of working with minimum supervision; 
• Good communication skills both verbally and in written form.

What we offer:

• Competitive salary; 
• Private healthcare;
• Life insurance;
• Pension plan above national standards;
• Relocation package;
• Additional free day;
• and more..