Senior Director of GMP Quality Assurance, Biologics - Remote

Overview

The Senior Director of GMP Quality Assurance, Biologics, position is critical to enable the rapidly growing company portfolio. This role reports to the Senior Vice President of Quality and serves as the Quality leader for Disc’s biologics programs.

In Short

• Setting quality strategy and driving Quality deliverables for biologics programs.
• Representing Quality on CMC and cross-functional leadership teams.
• Ensuring compliance oversight of manufacturing and supply chain operations.
• Reviewing analytical control strategies from IND through commercialization.
• Collaborating with internal and external stakeholders for risk-based decisions.
• Applying knowledge of US and ex-US regulations for biologics products.
• Fostering a positive workplace culture prioritizing collaboration.
• 20-30% travel required.
• Performing other business needs as identified by management.

Requirements

• BA/BS required; advanced degree a plus.
• 15 years of applicable GMP quality operations experience required.
• Experience in building Quality culture and supporting GMP operations.
• Experience in development of business processes and procedures.
• Proven track record of working on CMC and quality management reviews.
• Experience in clinical development of biologics is desirable.
• Self-driven, organized, and able to convey complex issues succinctly.

Benefits

• Comprehensive benefits package.
• Competitive compensation.
• Flexible work environment.
• Opportunities for professional development.
• Inclusive company culture.