Director, Quality Assurance (Quality Systems)

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Quality Assurance (Quality Systems) based in the United States. This leadership role sits at the center of global quality systems strategy, responsible for building, governing, and continuously improving a Pharmaceutical Quality System that supports both clinical and future commercial operations. You will own the design and execution of phase-appropriate GxP quality frameworks, ensuring compliance, scalability, and alignment across vendors, suppliers, and internal teams. The role includes leading the implementation and administration of an enterprise electronic Quality Management System (eQMS), making it a cornerstone of the organization’s quality infrastructure. You will serve as a key authority on quality systems, driving consistency across document control, training, deviations, CAPA, change management, audits, and risk management. This is a highly visible leadership position that blends strategy, systems ownership, and operational execution in a fast-evolving biotech environment. You will also play a critical role in building and mentoring a high-performing quality systems team while supporting regulatory readiness and inspection excellence. Accountabilities: Lead the design, implementation, and continuous improvement of a global Pharmaceutical Quality System (PQS) aligned with GxP and regulatory requirements. Serve as Business Owner and SME for the eQMS and PQS, overseeing core systems including document control, training, deviations, CAPA, change control, risk management, and audits. Drive the implementation, validation, and administration of an enterprise electronic Quality Management System (eQMS). Manage and continuously improve the internal audit program and ensure inspection readiness across functions and sites. Support and coordinate regulatory inspections, audits, and assessments with agencies, partners, customers, and third parties. Partner with supplier quality, manufacturing, and development teams to ensure alignment between PQS requirements and external quality systems. Develop, build, and lead a high-performing quality systems team aligned with organizational growth and maturity. Ensure compliance with FDA regulations, ICH guidelines, and global quality standards while enabling scalable business growth. Requirements: Approximately 10+ years of experience in pharmaceutical or biotechnology quality assurance, with deep expertise in quality systems. At least 5 years of leadership experience managing PQS or quality systems teams with direct reports. Proven experience implementing and leading enterprise eQMS platforms and quality system transformations. Strong knowledge of GxP regulations, FDA CFR requirements, and ICH guidelines. Experience hosting and managing regulatory inspections and leading remediation activities. Strong project management skills with the ability to manage multiple priorities in a fast‑paced environment. Exceptional leadership ability with a track record of building, scaling, and motivating high‑performing teams. Excellent communication and influencing skills across technical, operational, and executive stakeholders. Strong systems thinking mindset with high proficiency in enterprise platforms and digital quality tools. Bonus: advanced degree in Life Sciences, Engineering, or related field, and certifications such as ASQ CQA or RAC. Benefits: Competitive base salary range ($210,000–$230,000 USD). Eligibility for performance‑based cash incentives and equity compensation. Comprehensive employee benefits package including health, dental, and retirement plans. Remote‑first work environment with flexibility and focus on output. Opportunity to shape global quality systems strategy in a growing biotech organization. High‑impact leadership role with visibility across regulatory, operational, and executive teams. Domestic travel opportunities (up to ~10%) for audits, inspections, and collaboration. Strong focus on professional growth, leadership development, and quality culture building. #J-18808-Ljbffr Jobgether