Director, Compliance & Quality Systems
Role Summary
The Director, Compliance & Quality Systems owns ECL's Quality Management System (QMS). You will play an key role in finalizing the design, build, and implementation of the ECL QMS - a critical step toward GMP compliance - and you'll lead ECL through its first client audits and regulatory inspections. Once the QMS is established, you will oversee everyday operations and continuous compliance.
ECL operates from a single site today and will expand to additional sites in the near future. You'll ensure the QMS is designed to scale, so all sites launch with the same quality standard. You'll build and lead a focused team to drive GMP compliance.
This hands-on leadership role offers the opportunity to shape ECL's QMS, embedding quality processes directly into ECL's novel software-driven laboratory platform. We're looking for a leader with deep compliance expertise, as well as the curiosity and agility to reimagine how those requirements are met in a software-driven, connected environment.
Key Responsibilities
QMS Ownership:
- Own ECL's QMS processes end to end: document control, deviations, OOS, CAPA, change control, risk management, equipment qualification, supplier quality and GMP training
- Monitor QMS execution at current and future sites through quality metrics, periodic reviews, and internal audits
- Ensure the ECL QMS meets client quality requirements and the terms of each Quality Agreement, and that required client notifications are communicated accurately and on time
- Ensure quality and compliance requirements are embedded in ECL's single software platform
- Run Quality Management Reviews and report quality performance, risks, and resource needs to the executive team
Regulatory Intelligence and Readiness:
- Track changes in applicable regulations, guidance and standards and assess their impact on ECL operations and client work
- Monitor inspection trends, warning letters and enforcement themes, & translate them into concrete readiness actions
- Represent ECL's quality and compliance position with external stakeholders
Audits and Inspections
- Own the internal audit program, extending it to each new site as it opens
- Coordinate responses to observations and findings and track them to on-time closure
- Maintain continuous inspection readiness
- Manage client quality agreements and support client qualification questionnaires and due diligence
Supplier Quality
- Own supplier quality program: risk-based supplier selection, qualification, approved supplier list and ongoing performance monitoring
- Plan and conduct supplier audits; manage supplier corrective actions and change notifications
- Establish and maintain quality agreements with critical suppliers of instruments, reagents, consumables and services
Training
- Own the GMP training program at current and future sites
- Deliver quality, data integrity, and inspection-readiness training, updating content as regulations and procedures change
Leadership
- Build and lead a focused team supporting QMS and related activities
- Partner closely with the Quality leadership on strategy, priorities, and escalations
Qualifications
Required:
- Bachelor's degree in life sciences, chemistry, engineering, or related field
- 10+ years in quality assurance or compliance in a regulated laboratory, CDMO or biopharma environment
- 3+ years leading QA or QC teams
- Deep working knowledge of GMP requirements, including 21 CFR Parts 210/211 and data integrity expectations (21 CFR Part 11, EU Annex 11, ALCOA+)
- Direct experience in regulatory inspections and client audits, and writing responses that closed findings
- Experience with an internal audit program, supplier quality program and/or a GMP training program
Preferred
- Advanced degree (MS or PhD) in a scientific discipline
- Experience with ISO 9001 and/or ISO/IEC 17025
- Experience with computerized system validation (GAMP 5) and highly automated or software-driven lab operations
- Working knowledge of software development, such as coding, the software development lifecycle (SDLC) and version control
- Quality certification such as ASQ CQA, CQE or CMQ/OE
- Experience in a contract service organization supporting clients with differing quality requirements
