Director, Quality Operations

Cambridge, MA, United States
May 30, 2021
Required Education
Bachelors Degree
Position Type
Full time
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 Operations 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 operation activities within Omega and across a network of external vendors used for the development, manufacture and testing of Omega's portfolio of products. This role will develop and implement the strategy for product quality management processes and tools at Omega initially for early-stage clinical products and eventually for commercial products. The Quality Operations lead will ensure Omega's products are produced with the highest compliance, quality and regulatory standards to meet the program and company goals.

Key Responsibilities:
  • Develop and execute the quality operations strategy while ensuring that it aligns with the organization's business strategy
  • Hire, train, mentor and retain Quality Operations team; 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
  • Develop, implement and monitor quality programs, policies and procedures to ensure compliance with cGMP standards, FDA, EMA and other regulatory requirements
  • Provide quality oversight for external drug substance, drug product and clinical packaging facilities to provide support for operations, technology transfer, investigations and batch documentation reviews to ensure timely release of GMP materials for uninterrupted clinical supply and eventual transition to commercial supply
  • Using robust investigation tools, facilitate root cause analysis and drive robust actions to ensure the elimination of root cause for GMP operations; drives timely completion of deviations, CAPAs and change control for GMP operations
  • Support the evaluation/selection of potential future contract facilities and ensure quality agreements are in place with external vendors to ensure adherence to compliance requirements
  • Implement continuous quality improvement initiatives to drive product quality management systems and tools and ensure maximum productivity
  • Provides excellent customer service and create strong partnerships with internal and external partners
  • Assist with performing audits for external vendors
  • 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; 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 cGMP requirements for clinical manufacturing and global regulatory requirements; of GMP and global regulatory requirements
  • Strong leadership skills; demonstrated ability to lead a team and influence at all levels of the organization
  • Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective
  • An entrepreneurial approach to develop innovative ideas that will drive growth
  • Ability to effectively plan and implement stage-appropriate quality processes 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 with reviewing clinical and commercial regulatory filings
  • Experience in quality oversight of CTLs and CMOs is required
  • 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 Operations
  • Advanced understanding of all relevant GMP standards including knowledge of global regulatory requirements, including experience in quality oversight of drug substance, drug product and clinical packaging vendors for cGMP operations
  • Experienced Quality auditor
  • Experience in supporting internal plant development, validation, and operations
  • 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