Senior Director, Quality Assurance

About us:

Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology.

Our proprietary drug discovery platform, ReSOLVE^TM, gives us the ability to discover and develop medicines through unique insights into protein targets and to create dynamic blueprints that can guide the development of differentiated therapies at a fast pace. We aim to use the ReSOLVE platform to improve the way medicines are discovered and developed, with the ultimate goal of restoring the health of people facing serious illnesses.

Position Overview:

The Senior Director, Quality Assurance is responsible for establishing, implementing, and maintaining the company's Quality System to support the development, manufacturing, and clinical trials of our drug candidates. This newly created role will be responsible for establishing the internal Quality Assurance function, and will oversee all aspects of Quality Assurance, including GMP, GLP and GCP compliance, document control, training, audits, vendor qualification, and regulatory submissions. The ideal candidate will be a strategic thinker with a hands-on approach and a proven track record of success in a similar role within a small, fast-paced biotech environment. Small molecule drug development experience is required for this role.

Key Duties and Responsibilities:

• Lead and provide quality oversight and support to all product development programs; support of external manufacturing at CDMOs and CROs across all phases of development for starting material, drug substance, drug product intermediates, drug product and finished goods.
• Responsible for clinical batch disposition. Ensure review of batch data, including batch records, deviations, and other quality systems as applicable to determine acceptability of product disposition.
• Negotiate, monitor, and maintain Quality Agreements with Partners, CMOs, Contract labs, Vendors, where applicable.
• Ensure compliance with GCP for clinical trial activities.
• Ensures compliance with GLP for nonclinical studies.
• Lead investigations into quality issues, facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness.
• Further develop and support the Ventus electronic Quality Management System (eQMS), including Quality Plans, metrics to monitor effectiveness, and management reviews.
• Manage vendor qualification and audit programs for GMP, GCP and GLP compliance.
• Perform quality assurance activities associated with contracted GMP manufacturing, investigations, change control, investigations, and documentation.
• Lead/co-lead training and implementation of GXP procedures and quality systems.
• Partners with supply chain and other CMC team members to align on supply forecasts.
• Coordinates, identifies, and addresses issues and risks, drives resolution, and escalates on all levels to ensure timely resolution.
• Develops, tracks, manages, and reports on periodic quality management reports.
• Identifies and implements process and system improvements.
• Provides technical, quality oversight and support to the SVP of Regulatory and Quality in making quality decisions.

Requirements:

• A minimum of a BS/BA is required; advanced degree (MS or Pharm.D.) in scientific, regulatory, or related pharmaceutical field preferred.
• Minimum of 10 years of experience in the pharmaceutical, biotechnology or related industry.
• Expertise in GMP compliance, FDA guidelines, and international guidelines dealing with pharmaceutical manufacturing and Quality Assurance, quality standards, policies and procedures is required.
• In-depth understanding of quality processes/systems (e.g., change control, event handling, CAPA), risk management and manufacturing control strategies is also required with a good understanding of ISO regulations related to small molecule drugs.
• Extensive knowledge GCP and GLP, and other relevant regulations and guidelines, including how they are managed and scaled throughout the clinical phases.
• Experience with small molecule drug development is required.
• Experience managing the Quality Assurance function in a small, fast-paced environment is required.
• Strong leadership, communication, and interpersonal skills.
• Excellent problem-solving and analytical skills.
• This position can be remote, although proximity to one of our sites (Waltham, MA or Montreal, Quebec) is preferred. (#LI-REMOTE)