The Manager of Quality Systems and Compliance function at Wave Life Sciences will support the development and implementation of quality systems to ensure Wave’s quality systems are in compliance with US and international regulations, laws, and guidelines. Reporting to the Director of Quality Assurance the Manager will be accountable for quality systems including but not limited to training, documentation, quality metrics, and audits and inspections.
- Manage the Wave’s GxP Quality Management System including the Quality Policy and Quality Manual
- Oversee the electronic document control (EDMS) and training (LMS) systems
- Provide or support GxP/SOP training of all functional areas
- Coordinate and support the creation of and revisions to Standard Operating Procedures (SOPs)
- Develop GxP audit schedules, oversee execution of audit plans, track audit reporting and corrective/preventative actions
- Oversee external vendors responsible for GxP audit activities
- Manage internal audits, mock recalls, and lead preparations for and support preapproval and routine regulatory agency inspections
- Collect and report of quality metrics via Quality Management Reviews and the Quality Council
- Work with Director to provide long range planning of Quality System related activities including enterprise systems such as electronic document management, learning management, quality systems (Deviation, Change Control, CAPA)
- Promote a Quality Culture
- Mentor staff and build processes that will drive innovation, teamwork and efficiency within the organization
- BS degree in life sciences, chemistry or minimum of 10 years of experience in Biotech or Pharma and 5+ years' experience in Quality Systems management roles
- Ability to develop and implement GxP quality systems
- Knowledge of how to identify key quality metrics for maintaining compliance and identifying areas of improvement
- Experience in assisting inspections by regulatory agencies
- Understanding of domestic and international regulatory requirements
- Ability to effectively prioritize and manage multiple projects and tasks
- Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based decisions
- A team player, who listens effectively and invites response and discussion
- A collaborator who communicates in an open, clear, complete, timely and consistent manner
- Adaptability and Flexibility – The ability to adapt to working effectively within a variety of situations; adapts to organizational change and to changes in job demands.
- Communication and Teamwork – Ability to effectively express ideas in written and oral context; to work co-operatively with others;
- Relationship Building – Builds productive working relationships across a diverse spectrum of people.
- Organizational Skills – Ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.