Location: Sells,AZ, USA
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 At Roche, we are passionate about transforming patients' lives, and we are bold in both decision and action - we believe that good business means a better world. That is why we come to work every single day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. Roche is strongly committed to a diverse and inclusive workplace. We strive to build teams that represent a range of backgrounds, perspectives, and skills. Embracing diversity enables us to create a great place to work and to innovate for patients. As a Pharma Partnering Quality Lead, you will establish and maintain a comprehensive pharma partner audit schedule, leading both internal and external partner audits. Your role involves assisting Roche personnel in responding to audit observations and ensuring that corrective and preventive actions are effectively implemented. You will also identify process and procedure improvements, educate team members on current good clinical practices and quality system requirements, and serve as the primary point of contact for quality-related inquiries from external pharma companies. The Opportunity You collaborate across the chapter, function, division, and enterprise on Roche global initiatives for the consistent delivery of Pharma Quality support. You provide guidance and expertise to the lab and to pharma partners on current Good Clinical Practices (cGCP) including, but not limited to, global regulations, guidance, and standards. You assist the Lab Quality Site Lead in the execution of the internal audit program and partner with the Lab Quality Site Lead to incorporate customer feedback, from internal and external audits, into the lab quality management system and promote continuous improvement in lab processes and procedures. You manage Pharma Partnership Quality activities including: Establishing and maintaining Quality Assurance Agreements (QAA) with pharma partners, Collaborating with lab personnel to respond to Requests For Information (RFI) Leading internal and external audits and ensuring appropriate subject matter expert support and participation. Representing Roche Premarket Quality in customer support meetings Compiling and distributing customer specific Key Performance Indicators (KPIs) and reports Who You Are You have a Bachelors in Science or a Related Field You have 8 years experience in the medical device industry with a focus in Quality Assurance, Regulatory Affairs, or similar. You have comprehensive knowledge of regulations and standards related to Medical Devices (ISO 13485,FDA QSR, IVDR), Good Clinical Practices (ISO 20916, 21 CFR 812, GCLP), Clinical Laboratories, (ISO 15189, 42 CFR 493, New York State CLEP) and Pharmaceutical Trials. You hold strong leadership capabilities, with experience in leading cross-functional teams (Squad Lead, Matrix Lead) and driving change. Preferred You have experience with contract negotiation and familiarity with contractual language, project management, stakeholder management. You are knowledgeable of Medical Device and / or clinical laboratory auditing. Certification as a Quality Auditor is a plus. Travel percentage: Up to 10% travel, as needed Relocation assistance is available for this opportunity The expected salary range for this position based on the primary location of Arizona is $112,000 and $209,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits 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. Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Our integrated staining, workflow management and digital pathology solutions optimize laboratory efficiency to reduce errors and support diagnosis for pathology professionals. Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics. Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.