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Wave Life Sciences USA

Clinical-stage biotech developing stereopure oligonucleotides

Director Quality Systems

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeLexington, MA, USA

About the Job

Requirements

  • A Bachelor of Science in a scientific discipline is required.
  • At least 10 years of Quality Assurance experience in the pharmaceutical industry and 5 years managing personnel are required.
  • Significant expertise implementing and improving enterprise Quality Management Systems, Documentation Systems, and Learning Management Systems is required.
  • At least 3 years of Vendor Qualification and Management experience are required.
  • The candidate must be able to influence and collaborate with peers, develop and coach others, and oversee and guide colleagues’ work.
  • The candidate must be able to identify technical problems and suggest resolutions.
  • Knowledge of current Good Manufacturing Practice (cGMP) principles and relevant United States, European Union, and other regulatory guidance is required.
  • The candidate must be able to manage timelines for themselves and others.
  • The candidate must be able to work closely with teams and line functions to ensure Good Manufacturing Practice standards and compliance with global regulations.
  • Strong change management skills and a customer service mindset are required.
  • The candidate must have written, verbal, and presentation skills for interfacing with collaborators and customers.
  • The candidate must be able to assess complex issues, break them down, devise practical short-term solutions, and formulate long-term fixes.
  • Strong organizational skills, the ability to multitask and prioritize, adaptability to changing business needs, and the ability to meet timelines in a fast-paced environment are required.
  • The candidate must be self-motivated and demonstrate sound judgment and problem-solving skills.

Responsibilities

  • Improve and streamline existing Quality Management System processes, including Change Control, Deviations and Corrective and Preventive Action Management, Document Management, Good Practice training, and Vendor Management.
  • Assess the current state of Quality Systems and develop a staged plan to achieve inspection readiness.
  • Develop a team of Quality Systems personnel and foster collaboration, continuous improvement, and customer service.
  • Oversee the development, maintenance, and optimization of Quality Systems policies, procedures, and templates.
  • Ensure Quality Systems processes comply with applicable global regulatory requirements, including those of the Food and Drug Administration, European Medicines Agency, and International Council for Harmonisation.
  • Establish and monitor electronic Quality Management System performance metrics to ensure process effectiveness and compliance.
  • Lead cross-functional initiatives to identify and implement process improvements.
  • Foster innovation and proactive problem-solving within the Quality Systems team.
  • Act as a liaison between the Quality Systems team and other departments to align quality processes with business operations.
  • Communicate Quality Systems strategies, updates, and key metrics to senior leadership and other stakeholders.
  • Lead preparation for and responses to internal and external audits and regulatory inspections.
  • Perform other duties as assigned.

Desired Qualifications

  • Familiarity with drug development is a plus.
  • Veeva experience is highly desired.
  • Expertise in Computer System Validation principles through electronic systems implementation is desired.
  • Combination product experience is a plus.

About the Company

Wave Life Sciences USA

Clinical-stage biotech developing stereopure oligonucleotides

Wave Life Sciences develops stereopure nucleic acid therapies for genetically defined diseases. Its PRISM platform designs stereopure oligonucleotides that enable RNA interference, antisense silencing, splicing modulation, and RNA editing, including AIMers that recruit ADAR enzymes to edit RNA without changing the DNA. The company funds R&D mainly through partnerships and licensing (notably with GSK) and has programs in conditions like Alpha-1 antitrypsin deficiency, Duchenne muscular dystrophy, Huntington’s disease, and obesity. Its goal is to bring approved RNA medicines to patients by advancing a diversified pipeline and sustaining long-term collaborations that fund development.

Company size
201-500
Company stage
IPO
Headquarters
Cambridge, MA
Founded
2012

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