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The Position A healthier future. It is 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. That is what makes us Roche.
Reporting to the Quality and Regulatory Affairs Leader (QRAL), the Senior Quality Assurance Specialist is responsible for overall quality affairs for our DIAGNOSTIC and DIABETES CARE businesses. With support from QRAL, you will implement and perform activities necessary to ensure compliance with local regulation requirements and Roche Global Quality principles, policies and standards.
Key responsibilities include; Establishes the local case handling process to assure quality and timely execution of product complaints and inquiries. Conducts the training of the local personnel on complaints management. Verifies the locally identified Potentially Reportable Incident cases to ensure proper escalation to Global and conducts local assessment of PRI cases according to local laws including reporting to authorities. Manages Affiliate Notifications Safety Board Notifications (SBN) and Quality Notifications (QN) in accordance with MQMS. Supports other functions in the management of other affiliate notifications and performs product recall activities related to quality concerns. Liaise with all relevant associates to ensure that any product's safety issues are managed properly. Collects and reports to Roche Global Safety all adverse events occurring in affiliates and associated with Roche products in an accurate and timely manner. Ensures accurate and timely submission to Health Authorities of all product safety related matters, if required. Supports the QRAL in ensuring that the site complies with applicable Diagnostics Quality Standards/ MQMS and local regulatory requirements such as Training and communication, Monitoring of Q&R Metrics, Affiliate Notifications and Internal/ External audit, and Supplier Qualification. Informs affiliate about new/updated Diagnostics/Global SOP and these are incorporated into local procedures and all applicable staff is trained. Prepares for and manages health authority inspections by assuring the affiliate is operating in an "inspection ready" manner at all times. Participates in industry association to keep abreast of regulations and promote Roche position on regulatory issues. Who you are: Bachelor's/Master degree in Pharmaceutical or Science related field (preferably medical laboratory related). Minimum 2 years of experience in Quality Assurance in IVD/Medical Devices/Pharmaceutical Company, supervisory experience would be an advantage Extensive knowledge of the function and department process Proficient in both English and Filipino (written & spoken) Advanced computer skills and confident in giving presentations and negotiating Excellent interpersonal, organization and time management skills An analytical and problem-solving mindset Self-Initiative and proactive professional who values continuous improvement Able to develop and maintain a good network across multiple levels within the organization as well as externally. Able to influence, manage and make sound recommendations to all stakeholders. Willing to travel as per role requirements. Be inspired by who we are, what we do and how we do it. Visit to learn more about Roche.
Roche is an equal opportunity employer.
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.