About Omega Therapeutics:

Omega Therapeutics is a privately held, development-stage biotechnology company leveraging its proprietary epigenomic programming platform to biologically engineer a new class of programmable epigenetic medicines, known as Omega Epigenomic Controllers. Using these epigenomic controllers, Omega is seeking to transform the practice of human medicine through highly selective and direct control of the human genome to treat and cure disease.

Omega Therapeutics leverages its pioneering Epigenomic Programming™ platform to identify novel targets, develop first-in-class programmable epigenetic medicines, and enable rational drug development and manufacturing. Omega examines Insulated Genomic Domains (IGDs), the three-dimensional architecture of the human genome and its accompanying regulators and has identified and classified thousands of genomic “zip codes” across the ~15,000 IGDs as new drug targets. Omega’s new class of medicine, called Omega Epigenomic Controllers™, modulate IGDs using therapeutics that can be programmed to precisely up or down regulate single or multi-gene expression with controlled durability. These epigenomic controllers intervene at the pre-transcriptional level and they function without altering the native human genetic code or nucleic acid sequences. Using a rational and robust target identification and validation process, enhanced by a strong computational and data driven foundation, Omega is able to efficiently design and optimize potential epigenomic controllers from its platform. This entirely new and breakthrough approach allows the Company’s product candidates to also drug previously ‘undruggable’ targets across a broad range of diseases.

The Company is strategically pursuing specific disease targets that have not been successfully addressed through conventional modalities, including certain oncology indications, liver disease, serious inflammatory conditions, and acute respiratory distress syndrome (ARDS) among others. Omega’s mission is to deliver the transformative therapies of tomorrow.

About the Role:

Omega Therapeutics, Inc. is seeking a Director, Quality Systems to join our Technical Operations and Quality team. Reporting to the Senior Director and Head, Quality, this role will be responsible for establishing, implementing, and managing the quality systems activities within Omega and across a network of external vendors used for the development, manufacture, testing, non-clinical and clinical development of Omega’s portfolio of products. This role will develop and implement the strategy for quality management systems and tools at Omega to support non-clinical, clinical and eventually commercial processes. The Quality Systems lead will ensure Omega’s processes, systems and data are maintained with the highest compliance, integrity, quality and regulatory standards to meet the program and company goals.

Key Responsibilities:

  • Develop and execute the quality systems strategy while ensuring that it aligns with the organization’s business strategy
  • Oversee hiring to build an effective quality systems team; create and communicate a clear vision among direct reports, effectively align resources and motivating teams to achieve goals
  • Develop, implement and monitor quality programs, policies and procedures to ensure compliance with cGxP standards, FDA, EMA and other regulatory requirements
  • Develop and implement quality systems processes for document management, records management, training, event/CAPA, change management and vendor qualification and management
  • Provide quality oversight for vendor program and conduct audits for external vendors/manage resources for audit conduct
  • Ensure audits are conducted in alignment with business expectations, cGxP standards, FDA, EMA and other regulatory requirements
  • Implement continuous quality improvement initiatives to drive Quality systems and tools and ensure maximum productivity
  • Provide excellent customer service and create strong partnerships with internal and external partners
  • Review regulatory and technical documents for regulatory agency submissions serve as subject matter expert in regulatory interactions
  • Develop and implement contemporary, phase-appropriate quality practices that ensure appropriate metrics and key performance indicators to drive quality compliance and continuous improvement
  • Ensure that internal processes and metrics are aligned to create a high level of product quality and consistency
  • Provide direction and leadership to staff; establish realistic goals and objectives
  • Plan, direct and monitor work activities such that goals and objectives are accomplished efficiently, completely, within established timeframes and in compliance with department SOPs and cGMP regulations

 Required Skills:

  • Complete and advanced understanding of GxP requirements for non-clinical, clinical, manufacturing and global regulatory requirements
  • Strong leadership skills; demonstrated ability to lead a team and influence at all levels of the organization
  • An entrepreneurial approach to develop innovative ideas that will drive growth
  • The ability to effectively plan and implement stage-appropriate quality systems and set realistic goals to ensure timely and successful completion
  • Excellent oral and written communication skills; strong presentation and facilitation skills to effectively inform key updates and issues to executive leadership
  • Experience in quality oversight of CROs, CTLs and CMOs is required
  • Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective
  • Experience in leading, training and root cause analysis and effective investigation practices

Required Qualifications:

  • Bachelor’s degree in life sciences, analytical chemistry, engineering, or related field; advanced degree (MS or PhD) preferred
  • A minimum of 15+ years of leadership experience in all aspects of Quality Systems
  • Strong quality systems background to ensure value-added, phase-appropriate and effective quality systems
  • Experience in quality oversight and program management for GxP vendors
  • Experience in leading, training, and driving quality systems implementations
  • Experience in managing contract manufacturing partnerships and experienced Quality auditor
  • Experience in leading electronic quality management systems implementations
  • Strong lead in developing processes and controlled documents (e.g., SOPs, Policies, Specifications, Methods, etc.) as needed to ensure defined quality objectives are met
  • A natural self-starter with strong organizational skills that thrives in a busy, fast-paced environment, who communicates effectively with executive leaders and key external partners
  • Available to travel if/when needed

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