Senior Director / Director, Quality Operations

About Omega Therapeutics:

Omega Therapeutics is a privately-held, development-stage biotechnology company pioneering the field of epigenomic programming to precisely regulate and control the human genome to treat and cure disease. Omega's breakthrough science has enabled it to tap into nature's universal operating system, that epigenetically controls the human genome, to target the most fundamental genomic processes which fuel cellular growth, differentiation, and gene expression. Omega Therapeutics was founded by Flagship Pioneering in 2017 and currently has eight programs in various stages of preclinical development. The Company is strategically pursuing specific disease targets that have not been successfully addressed through conventional modalities, including liver disease, serious inflammatory conditions, acute respiratory distress syndrome (ARDS) and certain oncology indications, among others. Omega's mission is to transform medicine and deliver the therapies of tomorrow.

About the Role:

Omega Therapeutics, Inc. is seeking a Senior Director / Director, Quality Operations (commensurate with experience) to join our Technical Operations team. This person 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 systems and tools at Omega initially for early-stage clinical products and eventually for commercial products. S/he will be responsible for quality oversight of drug substance, drug product manufacturing and clinical packaging and labeling operations at external vendors. The incumbent manages investigations and batch release activities to ensure timely delivery of drug substance, drug product, and finished goods to ensure uninterrupted clinical supply. The Quality Operations leader will ensure Omega's vendors are with the highest compliance, quality, and regulatory standards to meet the program and company goals. This individual will be a key member of Technical Operations and play a significant role in building the organization as the company continues to scale and grow. As Omega prepares for significant growth, the Sr. Director/Director, Quality Operations will need the skills, experience, and maturity to work effectively in a dynamic, cross-functional, growing organization. S/he will hire, lead, and develop a Quality Operations team to successfully meet group objectives. The ideal candidate for this role is an experienced, natural self-starter with strong organizational skills that thrives in a busy, fast-paced environment, and who can communicate effectively with executive leaders and key leaders from external partners and customers.

Key Responsibilities:

• Develop and execute the quality operations strategy while ensuring that it aligns with the organization's business strategy
• 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, facilitates root cause analysis and drives 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 quality 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
• Oversee hiring to build an effective quality operations team; create and communicate a clear vision among direct reports, effectively align resources, and motivating teams to achieve goals
• Author/Review regulatory and technical documents for regulatory agency submissions serve as subject matter expert in regulatory interactions
• Develop and implement contemporary, phase-appropriate quality systems and 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; build and strengthen quality operation systems, determining the appropriate infrastructure and resources required to achieve business objectives

• Provide direction and leadership to staff by establishing 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 understanding cGMP requirements for clinical manufacturing and global regulatory requirements
• Proven ability to attract top talent and to build the quality operations team with an inspiring vision for the organization
• Strong leadership skills, including demonstrated ability to lead a team, and to influence at all levels of an organization
• The ability to effectively plan and implement stage-appropriate change management and set realistic goals to ensure timely and successful completion
• Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective
• Excellent oral and written communication skills, including presentation and facilitation skills, to effectively inform key updates and issues to executive leadership
• An entrepreneurial approach to develop new, innovative ideas that will drive growth within Quality organization
• Develop effective and efficient working relationships with both internal and external partners
• Available to travel if/when needed

Required Qualifications:

• Bachelor's degree in life sciences, engineering, or related field. Advanced degree (MS, Ph.D., or MBA) preferred.
• A minimum of 10+ years of experience in the biopharmaceutical/pharmaceutical industry in roles with increasing responsibility in quality operations.
• Strong quality operations background to ensure value-added and effective quality operations
• Experience in quality oversight of drug substance, drug product and clinical packaging vendors for cGMP operations is required
• Experience in leading, training, and root cause analysis and effective investigation practices
• Experience with authoring and reviewing clinical regulatory filings