Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities including RNAi silencing and RNA editing provides us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline is focused on our obesity, alpha-1 antitrypsin deficiency and PNPLA3 I148M liver disease programs and includes clinical programs for Duchenne muscular dystrophy and Huntington’s disease, as well as several preclinical programs utilizing our versatile RNA medicines platform. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.

Description

The Director, Quality Systems (QS) leads the internal team at Wave responsible for foundational quality processes: GXP Training, Document Control, Vendor Management, and Wave’s electronic Quality Management System (eQMS). This role is responsible for the continuous improvement and compliant operation of these processes to meet patient and business needs as Wave progresses from investigational products towards commercialization. This role is primarily focused on supporting GMP areas with some support of GXP. This is an onsite position requiring 4 days/week onsite presence at our Lexington facility.

Experience

BS in a scientific discipline
Minimum 10-12 years’ experience in Quality Assurance in the pharmaceutical industry and 5 years managing personnel
Significant expertise with implementation and improvement of enterprise systems: Quality Management Systems, Documentation Systems, and Learning Management Systems
Minimum 3 years’ experience with Vendor Qualification and Management
Demonstrated capability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues
Ability to identify technical problems and suggest resolution of the issues
Strong collaboration and communication skills
Ability to manage timelines for oneself and others
Knowledge of cGMP principles with respect to US, EU, and other relevant regulatory guidance and familiarity with drug development is a plus.

Responsibilities

Improve and streamline existing QMS processes, such as Change Control, Deviations and CAPA Management, Document Management, GxP Training, and Vendor Management
Assess current state of Quality Systems at Wave and develop a staged plan to arrive at inspection readiness
Develop a team of QS personnel fostering a culture of collaboration, continuous improvement and customer service
Oversee the development, maintenance, and optimization of QS policies, procedures, and templates
Ensure that all QS processes comply with applicable global regulatory requirements (e.g., FDA, EMA, ICH, etc.)
Establish and monitor eQMS performance metrics to ensure process effectiveness and compliance.
Lead cross-functional initiatives to identify and implement process improvements.
Foster a culture of innovation and proactive problem-solving within the QS team
Act as a liaison between the QS team and other departments to ensure alignment of quality processes with business operations
Communicate QS processes strategies, updates, and key metrics to senior leadership and other stakeholders
Lead preparation and response activities for internal and external audits and regulatory inspections
Other duties as assigned

Key Skills

Hands-on self-starter with the ability to collaborate and work closely with various teams and line functions to ensure GMP standards and compliance with global regulations
Demonstrated ability to coach and develop personnel
Strong change management skills with a customer service mindset
Excellent written, verbal and presentation skills for effectively interfacing with collaborators and customers