Pfizer Strängnäs is a modern world class multi product manufacturing site situated in the picturesque surroundings of Strängnäs. The site is one of Sweden’s largest Biotech facility for commercial manufacturing of pharmaceutical drug substances with approximately 250 employees. Pfizer Strängnäs has a Quality Operation (QO) that consists of approximately 65 colleagues. The quality Operation is now recruiting an Operation Lead who will be the overall responsible for Quality Operations of the site and the provide operational and strategic leadership for the department and its coworkers. In your role your main responsibility is to manage the local Quality Operations (QO) team, including Manufacturing Quality (MQ) and Quality Control (QC), and to establish, maintain and improve an effective Quality Management System (QMS) in compliance with internal and external standards/requirements/dossiers within PGS Strängnäs and over the entire life cycle of the product or material. The Quality Operations Lead will have three managers and the QP directly reporting. The Quality Operation Lead will play an important role in the management team of the Site Operations as well as to the Global Quality management team for Pfizers Biotech sites.
You will work with frontline formulations to the growing market of Biologics and will be given the opportunity to both influence the develop the QO at the Pfizer Strängnäs site and together with your international colleagues.
Your area of responsibility will involve:
• Manage, develop and assign resources to the quality operations team at PGS Strangnas.
• Ensure that an effective system is in place to monitor effectiveness and compliance of the Quality Management Systems (QMS) throughout PGS Strangnas.
• Ensure the development, implementation, maintenance and improvement of quality systems/processes QA and QC.
• Communicate to leadership on a frequent basis the key quality performance metrics used to demonstrate QSM effectiveness.
• Establish processes to interface with key stakeholders, such as Regulatory Affairs (RA), Global Chemistry Manufacturing Controls (GCMC) and others to ensure efficient workflow.
• Establish, maintain and improve an effective Supplier Quality Management system for the site.
• Manage third-party inspections and to perform self appraisals and supplier audits.
• Manage the site budget and headcount within the area of responsibility.
• Keep current with Pfizer standards, guidance and regulations.
How to apply:
Apply at www.dfind.se/science-engineering. In this recruitment Pfizer is collaborating with Dfind Science & Engineering. For information contact Senior Recruitment consultant Ellinor Crafoord, +4673-3434502. We would like to have your application in English as soon as possible but not later than 2018-08-06. We will take questions and start calling for interview more intensively from the 16th of July. I you have questions before please email them to firstname.lastname@example.org.
Position: Fulltime, open-end
Location: Strängnäs, Sweden
• A Master degree in a Science or Engineering
• Solid knowledge of global GMP and regulatory requirements
• At least 10 years’ experience in pharmaceutical manufacturing and major parts of that in Quality
• At least 5 years of personal management and/or leadership
• Experience of working in a global environment
• Fluent in written and spoken Swedish and English
Experience in working with manufacturing processes for Biologics is a strong merit
• Strong leadership skills.
• Process oriented, analytical and problem solving abilities.
• Excellent organizational and interpersonal skills.
• Excellent written and verbal communication skills.
Pfizer Strängnäs is one of Sweden’s largest Biotech facility for commercial manufacturing of pharmaceutical drug substances with approximately 230 employees. They manufacture several drug substances and protein intermediate in a multi-product and a dedicated facility. The Quality Operation is organized in one QA team, one QA Compliance team and a QC team. The function consists of approximately 65 colleagues. You will work closely with both QA, QC and QA Compliance colleagues and be part of the QO leadership team. You will report directly to the QO Director. Pfizer is a company that focuses on innovation, creativity and respect for patients, colleagues and society. We have an effective manufacturing organization with focus on continuous improvements, Six Sigma and Lean.