Responsibilities and Duties:

• Translate regulatory requirements into actionable policies and procedures that are phase appropriate and aligned with quality agreements negotiated with partners.
• Author quality agreements for service providers (CDMOs, CROs, etc.) and suppliers (APIs, excipients, raw materials, reagents) in a phase appropriate manner.
• Educate staff using a “What, Why, When” approach to regulations and implement cost effective solutions research and translational development.
• Train staff team on procedures and audit laboratory notebooks, research records, electronic systems, etc. for compliance with established policies.
• Develop, implement, and maintain a comprehensive quality management system in accordance with industry standards and regulatory requirements.
• Conduct regular assessments to identify opportunities for continuous improvement within the quality system.
• Oversee the creation, review, and approval of quality-related documents, including standard operating procedures, protocols, and reports.
• Implement document control processes to ensure accuracy, completeness, and traceability of records.
• Stay current with applicable regulations and guidelines related to late-stage biotech development and ensure the organization's compliance.
• Collaborate with cross-functional teams to prepare for and participate in regulatory inspections.
• Audit service providers (CDMOs, CROs, etc.) and suppliers (raw material, API, reagent, etc.) for compliance with regulations and execution consistent with quality agreements.
• Foster a culture of excellence, collaboration, and continuous improvement within the technical team.

Education and Experience

• Bachelor's or advanced degree in a relevant scientific or engineering discipline.
• Proven experience in quality assurance within the biotech or pharmaceutical industry, with a focus on research and translational development.
• Strong understanding of regulatory requirements, including FDA and EMA guidelines.
• Excellent organizational, communication, and interpersonal skills.
• Ability to lead and influence cross-functional teams.
• Detail-oriented with a commitment to maintaining the highest standards of quality.

Core Skills and Competencies

Salary and Benefits

• Annual Salary Range: $110,000 - $130,000 DOE

All full-time employees are eligible for the following benefits.

• Stock Options
• 401(k) with generous Company match
• Flexible work schedule
• Generous PTO
• Health, Dental and Vision insurance
• Short Term Disability insurance and Voluntary AD&D Insurance