DIRECTOR, QUALITY ASSURANCE (QUALITY SYSTEMS)

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. How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1