As a the Product Quality Lead (PQL) you will be accountable for the program quality throughout the whole lifecycle of Polpharma Biologics’ product, identifying the risks and creating solutions. The PQL represents Quality function in the cross-functional project teams with responsibility for oversight of the overall quality of the project. Furthermore, the PQL develops the quality strategy of the program; coordinates Quality activities for the biosimilar program across the interna and external network; provides functional expertise and guidance and communicates project needs to quality functional areas.

Your responsibilities include, but are not limited to:

• Representing Group Quality of Polpharma Biologics for biosimilar program, supporting Polpharma Biologics biosimilar Program Lead by coordinating all Quality sites and functions, and by working collaboratively with line function units (i.e. facilities, engineering, scientific experts) to support establishment of biosimilar production and testing facilities at internal or external sites;
• Communicating project needs to quality functional areas (foe example: site quality, external manufacturing quality, quality compliance, device quality, etc.);
• Providing expert quality guidance related to quality standards, relevant quality guidelines, regulations and requirements for biosimilar manufacturing and testing, in both clinical and commercial phase;
• For the assigned programs, overseeing the overall quality of late process development, technical transfer to GMP manufacturing, preparation for process and analytical method validation, stability, and release activities for internal and 3rd party network;
• Working individually and in cooperation with others to ensure adequate Quality Oversight of the assigned program; 
• Providing Product Quality Stewardship for the biosimilar by assessing and providing decisions with respect to Change Control management deviations, investigations, CAPAs and complaints;
• Escalation of product specific quality and compliance issues;
• Performing and supporting product specific risk assessments;
• Quality oversight of activities such as analytical method transfer, manufacturing process transfer, product comparability, process characterization, process validation, on-going process verification;
• Representing Quality for Regulatory filing strategy, perform review of CMC sections as required for initial submissions and during lifecycle management of the biosimilar;
• Potentially being assigned as single point of contact for Third Parties being responsible for the quality oversight of assigned CDMO. 

If you have:

• 10 or more years of experience in the biotech industry, with direct experience with biopharmaceutical products. Experience with antibodies is an advantage;
• Experience in QA operations, production, QC and/or other relevant operational areas, preferably including minimum 5 years in QA, and 3 years of management and/or project management experience;
• Significant experience with manufacturing and/or testing of monoclonal antibodies derived cell culture Drug Substance / Drug Product (fed-batch or perfusion processes);
• Solid experience with Validation, Technical Transfers, Launches, Lifecycle Management of Products;
• Experience with third-party management;
• Experience with US FDA PAI;
• Practical knowledge of MS Office;
• Very good command of English language, including written and oral communication and presentation skills;
• Solid management skills with respect to planning/tracking, prioritizing and project timelines;
• Ability to influence people without direct authority, negotiation, and communication;
• Excellent technical writing skills.

What we offer:

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