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United States
Onsite
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Compliance & Quality Systems based in the United States.
We are seeking an experienced quality and compliance leader to own and advance a comprehensive Quality Management System (QMS) within a regulated laboratory environment. You will lead the final design, implementation, and ongoing operation of the QMS, ensuring alignment with Good Manufacturing Practice (GMP) requirements and client expectations. As the organization prepares for its first client audits and regulatory inspections, you will establish robust processes and maintain continuous inspection readiness. You will also build a quality framework that can scale across multiple sites while maintaining consistent standards. Working at the intersection of quality assurance, regulatory compliance, and software-driven laboratory operations, you will help embed quality controls directly into a connected technology platform. This hands-on leadership opportunity combines strategic ownership, team development, and operational execution.
As Director, Compliance & Quality Systems, you will oversee the full quality and compliance framework, ensuring that processes remain effective, scalable, and aligned with regulatory and client requirements. Your responsibilities will include:
Quality Management System ownership: Lead the design, implementation, and ongoing management of the QMS, covering document control, deviations, out-of-specification (OOS) investigations, corrective and preventive actions (CAPA), change control, risk management, equipment qualification, supplier quality, and GMP training.
Quality performance and oversight: Monitor QMS execution across current and future sites through quality metrics, periodic reviews, and internal audits. Conduct Quality Management Reviews and report performance, risks, and resource requirements to the executive team.
Client quality requirements: Ensure compliance with client quality requirements and Quality Agreements, including accurate and timely communication of required client notifications.
Software integration: Ensure quality and compliance requirements are embedded within the organization's unified software platform and laboratory workflows.
Regulatory intelligence and readiness: Track relevant regulatory developments, guidance, standards, inspection trends, warning letters, and enforcement themes. Translate these insights into practical actions that strengthen operational compliance and inspection readiness.
Audits and inspections: Own the internal audit program and extend it to new sites as they open. Lead preparation for client audits and regulatory inspections, coordinate responses to observations and findings, and ensure corrective actions are completed on time.
Client qualification and due diligence: Manage client Quality Agreements and support qualification questionnaires, audits, and due diligence activities.
Supplier quality management: Develop and oversee a risk-based supplier quality program, including supplier selection, qualification, approved supplier lists, performance monitoring, supplier audits, corrective actions, and change notifications. Establish and maintain quality agreements with critical suppliers of instruments, reagents, consumables, and services.
GMP training: Own the GMP training program across all sites. Deliver and update training on quality, data integrity, and inspection readiness as regulations and procedures evolve.
Team leadership: Build and lead a focused quality team, partnering with senior Quality leadership on strategy, priorities, and escalations.
The ideal candidate is a seasoned quality assurance professional with strong regulatory expertise, proven leadership experience, and the ability to build effective compliance systems in a technology-enabled laboratory environment. You should bring:
A bachelor's degree in life sciences, chemistry, engineering, or a related discipline.
At least 10 years of experience in quality assurance or compliance within a regulated laboratory, contract development and manufacturing organization (CDMO), or biopharmaceutical environment.
At least 3 years of experience leading QA or QC teams.
In-depth knowledge of GMP requirements, including 21 CFR Parts 210 and 211.
Strong understanding of data integrity requirements and principles, including 21 CFR Part 11, EU Annex 11, and ALCOA+.
Direct experience managing regulatory inspections and client audits, including preparing responses that successfully address and close findings.
Experience developing or managing internal audit programs, supplier quality programs, and/or GMP training programs.
Strong leadership, communication, and stakeholder management skills, with the ability to represent quality and compliance positions effectively.
The ability to translate regulatory requirements into practical, scalable operational processes and maintain a proactive approach to risk management.
Preferred qualifications:
An advanced degree (MS or PhD) in a scientific discipline.
Experience with ISO 9001 and/or ISO/IEC 17025 standards.
Knowledge of computerized system validation (GAMP 5) and highly automated or software-driven laboratory operations.
Working knowledge of software development concepts, including coding, software development lifecycles (SDLC), and version control.
A relevant quality certification, such as ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or Certified Manager of Quality/Organizational Excellence (CMQ/OE).
Experience working in a contract service organization supporting clients with different quality requirements.
Opportunity to own and shape a comprehensive GMP-aligned Quality Management System.
Hands-on leadership role with the ability to build and develop a dedicated quality team.
Direct influence on quality strategy, regulatory readiness, and operational standards.
Opportunity to help scale quality systems across multiple laboratory sites.
Exposure to innovative, software-driven laboratory operations and the integration of technology into regulated quality processes.
