At Arbutus, we have a vision: to cure chronic Hepatitis B virus (HBV). We have a dedicated and innovative team and we are uniquely positioned to transform the HBV treatment landscape. We are developing a portfolio of drug candidates with multiple mechanisms of action that we believe will result in a combination therapy to cure HBV.
If you are looking to join a team with a proven track record in drug discovery and development, and are as passionate as we are, we want to hear from you.
Reporting to Senior Director Quality, the Director, Quality Assurance will be responsible for leadership and management of Arbutus’ Quality Management System to advance products in Arbutus’ diverse pipeline through clinical phases of development in line with corporate and project objectives.
Duties and responsibilities:
• Overall responsibility for development, implementation and improvement of Arbutus GxP quality systems including the electronic document management system, SOPs and processes such as change control, non-conformances, investigations, training, internal audit, CAPA and document review and approval
• Responsibility for Vendor Qualification and Management, including Contract Manufacturing and Testing, pre-clinical and clinical CROs. Conduct on-site audits, and participate in regulatory inspections at contractor sites, as required
• Perform release and disposition functions; manage and control cGMP-manufactured intermediates and products; work with Qualified Persons as required
• Overall responsibility for document management process, including controlled records
• Provides expert technical knowledge in quality assurance in support of group, departmental and cross functional project objectives
• Ensures that all activities are conducted in compliance with any pertinent regulatory requirements, and in accordance with scientific standards, ethical and professional values, management philosophy, established priorities, safety policies and practices of the company
• Manages internal and/or external resources to accomplish the responsibilities of the role
• BS, MS, or PhD in a related discipline, with a minimum of 10 years’ experience in a quality assurance or related role.
• Progressive experience in the pharmaceutical industry required; experience working in a fast paced biotech environment preferred.
• Track record in developing and managing GxP Quality Systems through clinical phases of development to product approval.
• Thorough knowledge of ICH Guidelines, GxP and related regulatory guidances.
• Proven track record of building and maintaining strong relationships with internal and external stakeholders.
• Ability to manage deadlines and prioritize effectively, while maintaining flexibility.
• Track record of effective business process improvements and systems implementation, including strong change management skills.
• Excellent communication and interpersonal skills; able to communicate with variety of audiences and collaborate effectively with a variety of internal and external stakeholders.
• Pragmatic and strategic thinker who meets objectives and leads by example.
• Quality professional certification preferred, especially CQA.