Senior Director, Quality Management Systems & Compliance

Responsibilities:
- Set overall strategic direction for the quality management system (QMS) and digital compliance initiatives
- Lead capacity planning for capabilities to support growth strategies and pipeline expansion
- Prepare the organization for future innovations and commercial product expansion; support enterprise objectives through quality governance

QMS Governance:
- Establish and maintain a global QMS governance framework for regulatory requirements, industry standards, and company policies
- Develop and implement GxP standards, procedures, and best practices across cell and gene modalities and geographies
- Provide oversight for Management Review, Management Notification, Trending, Quality Planning & Continuous Improvement, Material Review Boards, complaints, and recall processes

Risk Management & Compliance:
- Develop and oversee risk-based approaches for quality system governance
- Proactively identify and mitigate compliance risks; monitor regulatory trends
- Serve as subject matter expert for inspection readiness and interact with Health Authorities; draft responses to observations

Performance Management & Analytics:
- Define global effectiveness/efficiency metrics; implement QMS KPIs
- Evaluate quality system health across modalities/GxP/geographies; drive continuous improvement using analytics
- Lead IT/systems leadership for GxP computer systems lifecycle (21 CFR 11/Annex 11/GAMP 5)

Team Leadership & External Engagement:
- Develop and mentor cross-functional QMS experts; lead harmonization and foster a quality culture
- Manage product complaint handling activities; represent organization in industry forums

Qualifications:
- Deep knowledge of GxP regulations and QMS frameworks across multiple modalities
- Proven track record leading organizational transformations
- Strong analytical/strategic thinking; leadership and cross-functional collaboration
- Experience with regulatory inspections/Health Authority interactions
- Experience across small molecule, cell, and gene therapy; global experience with FDA/EMA (etc.)
- Advanced data analytics and performance management systems
- BS/MS/PhD in science, engineering, pharmacy, or medicine
- 15+ years in pharma with quality compliance leadership across R&D, commercial manufacturing, pharmacovigilance, and information quality

Application instructions:
- Applications accepted on a rolling basis until the position is filled.

Compensation/benefits (as stated):
- Base salary: $251,771.00–$307,721.00 USD/year; performance-based annual bonus; new hire equity grant; potential annual equity awards.