Head of Quality Assurance

The Position At Roche, we believe it is urgent to deliver medical solutions right now, even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are brave in both decision and action and we believe that good business means a better world. A Chapter Lead is a critical member of the Australian Enabling Team (Leadership Team) whose mission is to champion the overall vision, strategy and direction for our organization, to create a caring and empowering environment for our people to make decisions on how best to achieve our vision, and to create a customer-obsessed organisation that actively engages with stakeholders across the healthcare ecosystem. The Head of Quality Assurance, titled Chapter Lead- Quality Assurance within Roche, is an empowered leader and the local face of Roche who provides enterprise leadership to a highly externally-focused organization including stakeholders and partners, ensuring alignment with local and global regulations, license to operate requirements and adherence to the Roche Group Code of Conduct As a Chapter lead, you will play a crucial role in pioneering life-changing healthcare for every Australian. You will build up-to-date knowledge and survey future trends related to a chapter’s area of focus. You will demonstrate Creative Leadership competencies and play the role of Visionary, Architect, Catalyst and Coach, developing and empowering Roche employees to innovate, collaborate, be authentic and own their impact. In this role, you will work constructively with other Chapter Leads to have the right people in the right place at the right time to deliver organisational priorities. You will lead a large complex team that works across complex healthcare ecosystems and use their deep expertise to provide thought-out strategic direction that helps to balance external ecosystem needs with the overall priorities and licence to operate requirements of the Affiliate, both in terms of appropriately bringing the outside in and in terms of prioritised, shared value, work packages in response to individual ecosystem needs. As Roche Australia holds a TGA GMP license, qualified personnel are required to carry out all the tasks which are the responsibility of the manufacturer, specifically an authorised person for release is required. In addition to the responsibilities as Australian Qualified Person, the Chapter Lead - Quality Assurance may at any time be required to complete tasks in relation to the development, implementation and maintenance of Quality Systems required for GxP compliance to Health Authority and Roche PQS requirements within quality operations according to the resource needs of the department, relevant Communities of Practice, Squads or other affiliate as part of a networked approach to ways of working. The Chapter Lead- Quality Assurance is the primary escalation point for any GMP quality issue within the Australian Affiliate and acts as a back-up for the New Zealand Affiliate in this capacity, and, as the authorised person, is the local decision maker for any Global Expert Group Meetings affecting products within the local jurisdiction. The Chapter Lead- Quality Assurance wears many hats that includes Authorised Person, Head of Quality Control and Head of Quality Assurance; responsibilities related to these roles include but are not limited to; All medicinal products are compliant with the Australian laws and in accordance with the requirements of the Marketing Authorisation and Good Manufacturing Practice; Take responsibilities relating to quality including in particular the design, effective implementation, monitoring and maintenance of the Pharmaceutical Quality System. To approve or reject starting materials, packaging materials, intermediate, bulk and finished products; To ensure that all necessary testing is carried out and the associated records evaluated; To approve specifications, sampling instructions, test methods and other Quality Control procedures; To ensure that the appropriate validations are done; To ensure that the required initial and continuing training of personnel is carried out and adapted according to need. The approval and monitoring of suppliers of materials; The retention of records; The inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality; Participation in management reviews of process performance, product quality and of the Pharmaceutical Quality System and advocating continual improvement; Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management. Who you are: You have a University Degree or equivalent in Science or related field with appropriate job-related experience and expertise commensurate with the expectations of the role, including at least 5 years of experience in leadership roles within the quality area. With In-depth knowledge of the Pharmaceutical/biotechnology or related industry, you have strong customer focus and a keen eye on delivering exponential patient value As a Subject Matter Expert, you are experienced as a highly creative leader of cross-functional and networked teams, who knows how to both find and develop diverse talent and connect them to the wider enterprise. With a growth mind-set, curiosity and focus on continuous improvement, you have demonstrated strength in agile working principles and methodologies and proficiency in planning and managing resources to deliver objectives. In return, you will be provided with a rewarding and challenging role, a supportive work environment in which you can grow and develop your skills, the opportunity to work for a market-leading organisation, and a competitive remuneration package. This role is only open to candidates that have full eligibility to live and work in Australia. Please note that we do not accept any unsolicited resumes or enquiries from recruitment agencies- Roche has a dedicated in-house Talent Acquisition team. What do we offer In return, Roche offers a competitive package, ongoing development, and opportunities for career advancement. Roche encourages a high-performance culture where you are empowered and trusted to make decisions. We strive for excellence and extraordinary results and take a genuine interest in our people and their well-being, and our patients. At Roche, the world’s largest biotech company you can, with the industry’s strongest pipeline in specialised medicines. Take pride in knowing you can make a difference to millions of patients worldwide developing treatments for oncology, neuroscience, inflammation, immunology, ophthalmology, rare diseases, and respiratory disease. Anything’s possible, in a friendly, collaborative culture where people are united in purpose and will stretch you to be brave, speak up and think differently. Feel empowered to deliver meaningful outcomes, supported by accessible and inspiring leaders. All facets of diversity are important to us and we endeavour to create an environment where everyone, regardless of factors such as gender, age, ability, race, ethnicity, sexual orientation, gender identification or religion, can contribute and realise their potential. As part of promoting diversity, we welcome applications from all people who are passionate about doing now what patients need next. We are committed to providing a safe, secure and healthy workplace, and to minimise any such impacts to our employees, customers and the community. In line with our vaccination policy all of our employees are required to be fully vaccinated against COVID-19. By applying for this role, you acknowledge your awareness of this policy and the requirement to comply if employment is secured. We encourage you to advise of any individual circumstances that may require consideration. 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. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each 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. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.