Site head of quality

3 weeks ago


Singapore F. Hoffmann-La Roche Gruppe Full time

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters. The Position Site Head of Quality A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. The Quality Site Head is accountable for the quality of the products manufactured at the site and ensures compliance with valid specifications and c GMP requirements. The Quality Site Head is accountable for the quality of the clinical, commercial and launch products and ensures compliance with valid specifications and c GMP requirements. The focus of Singapore is Drug Substance manufacturing (CHO and E.coli). The Quality Site Head is a member of the Quality Manufacturing Unit Leadership Team, an extended Pharma Technical Operations Quality Leadership Team member, a member of the Site Leadership Team and partner to the Site Head. The Opportunity Accountable to ensure compliant manufacturing operations and that the manufactured product meets global Health Authority regulations, Company standards and expectations as well as develop strategic goals and objectives to support the monitoring, review, testing and timely reporting on the quality of Roche/Genentech products. Provide leadership and guidance to staff directing Quality & Site Compliance functions, manage performance and development within the entire Quality organisation at the Site to ensure achievement of organizational and departmental goals. This is in line with building a high performing team with strong Site-and-Network impact. Proactively prepare for and manage Health Authority inspections by ensuring the site is operating in an “inspection ready” manner at all times. Prepare adequate and timely responses to any inspection observations and implement appropriate and thorough corrections, as necessary. Maintain an effective Quality governance and continually improve the governance to meet business and compliance needs. Additionally, stay on-top of technical challenges and deviations and support sustainable resolution with an operational relevant Quality organisation. This includes Site specific as well as Roche Pharma Technical network topics/program contributions. Serve as final decision-maker and spokesperson for the Quality Unit. This role is the decision maker for the Quality Unit at the Site. Besides that, the role will establish and manage the Quality Unit organizational, managerial and accountability structures. Who you are You should hold a Bachelor’s degree and above in Life Sciences, Pharmacy or equivalent with minimum 20 years of related working experience in the Pharma/Biopharmaceutical industry with 10 years working in Quality, Compliance, Regulatory and/or Validation, preferred as well as 7 or more years of people management experience in managing direct and indirect of workforce (50 individuals). You should possess excellent knowledge of the HSA, US, European, and International c GMP regulations and the QM/QRM techniques with an ability to adequately interpret and implement quality standards. Demonstrated experience in HSA, US, European and other relevant Health Authority inspections is a must. Who we are At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. Roche is an Equal Opportunity Employer. #J-18808-Ljbffr



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