Director, Quality Assurance (Quality Systems)
Based in the United StatesFull-TimeDirector
Salary$210,000–$230,000 USD
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Job Details
- Experience
- Approximately 10+ years of experience in pharmaceutical or biotechnology quality assurance
- Required Skills
- Quality AssuranceRisk Management
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.
Responsibilities
- 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.
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