Senior Director, Quality Management Systems & Compliance (Gene Therapy)

Location: Cambridge, MA, United States; remote work indicated by the posting.

Base salary: $251,771–$307,721 USD per year, plus performance-based annual cash bonus, new-hire equity grant, and potential annual equity awards.

Company

hirify.global develops curative genome-editing treatments for severe and life-threatening diseases.

What you will do

• Set the strategic direction for the global quality management system and digital compliance initiatives.
• Lead QMS governance, GxP standards, quality planning, management reviews, trending, complaints, recalls, and continuous improvement across cell and gene therapy modalities.
• Develop risk-based compliance approaches, monitor regulatory trends, prepare for inspections, interact with Health Authorities, and draft responses to regulatory observations.
• Define global effectiveness metrics and KPIs, evaluate QMS health, and use analytics to support data-driven decisions.
• Partner with IT and system owners to maintain compliant GxP computer-system lifecycles and accurate reporting.
• Lead, mentor, and develop quality professionals and cross-functional subject-matter communities, including the product complaint handling team.

Requirements

• 15+ years of pharmaceutical-industry experience, including quality compliance leadership across research and development, commercial manufacturing, pharmacovigilance, and information quality.
• Deep knowledge of GxP regulations, QMS frameworks, and regulatory requirements across multiple modalities.
• Experience leading organizational transformations, regulatory inspections, and Health Authority interactions.
• Experience across small-molecule, cell, and gene therapy modalities and with global regulatory agencies including FDA and EMA.
• Advanced knowledge of data analytics and performance-management systems.
• BS, MS, or PhD in science, engineering, pharmacy, medicine, or a related field.

Culture & Benefits

• Work supports the development of genome-editing treatments intended to transform patient lives.
• Culture is based on the values One, Explore, Disrupt, and Deliver.
• Benefits include a performance-based annual cash bonus and equity opportunities.
• Applications are reviewed on a rolling basis until the position is filled.