Director, GMP Systems - Cellares
View Company Profile- Job Title
- Director, GMP Systems
- Job Location
- South San Francisco, CA
- Job Description
- We are seeking a Director, GMP Systems, who will be a hands-on technology and operations leader responsible for stabilizing, scaling, and continuously improving Cellares’ GMP-critical digital backbone as the company transitions from clinical manufacturing to repeatable, audit-ready, pre-commercial operations.This is a player-coach role. The Director is expected to operate at both strategic and execution levels driving solution decisions, resolving cross-system issues, guiding configuration and data decisions, and directly intervening when necessary to stabilize critical initiatives. The role acts as a bridge between business execution and system delivery, bringing structure, governance, and clarity without slowing innovation.Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.Responsibilities
- Operational ownership and execution oversight for business-critical and GMP-impacting systems such as: ERP, Manufacturing Execution & Automation Interfaces, Quality Management Systems (QMS), PLM, Integration & Workflow Platforms, Data & Analytics
- Define and execute the GMP systems strategy aligned with manufacturing scale and commercial readiness
- Act as the primary systems partner to Manufacturing, Quality, Supply Chain, Engineering, and Finance leadership
- Translate evolving operational needs into practical, compliant system solutions
- Ensure systems support operational execution, compliance, and unit economics
- Ensure manufacturing execution data, inventory, and quality events flow accurately across systems
- Enable reliable WIP visibility, inventory valuation, and cost capture early to avoid pre-commercial rework
- Support manufacturing readiness without over-engineering controls prematurely
- Partner closely with the Integration Architecture & Data Foundation teams to ensure alignment with enterprise architecture and long-term data strategy.
- Provide business and GMP requirements for integrations across ERP, MES, QMS, and automation platforms.
- Ensure data integrity, traceability, and auditability across manufacturing, quality, and finance processes
- Drive root cause resolution for cross-system issues (data, integration, configuration, or process)
- Establish operational discipline for transports, releases, documentation, and validation support
- Improve business confidence that GMP systems are stable, predictable, and audit-ready
- Provide hands-on leadership to drive execution of critical GMP system initiatives
- Establish clear priorities, milestones, and operational accountability for internal teams and vendors
- Provide day-to-day direction to system integrators and support partners
- Partner with IT leadership and Procurement on vendor strategy and performance management
- Actively intervene to stabilize, course-correct, or accelerate initiatives as business priorities evolve
- Introduce lightweight governance, release discipline, and decision clarity
- Improve confidence from QA, Manufacturing, and leadership that systems “just work”
- Position IT and systems as business enablers rather than bottlenecks
Requirements- Bachelor's in Industrial Engineering, Computer Science, or related field
- 12–15+ years leading enterprise and manufacturing systems in regulated product companies
- Deep experience across ERP, MES, QMS, LIMS and manufacturing data flows
- Proven ability to stabilize and scale underperforming systems
- Strong partnership with Manufacturing, Quality, Supply Chain, and Finance leaders
- Hands-on leadership style, strategic but deeply execution-oriented and comfortable working directly with configurations, data issues, and operational problem resolution
- Experience in highly regulated manufacturing (biotech, medical devices, pharmaceutical, aerospace, or similar)
- Experience building systems before commercial scale
- Track record of translating complex operations into simple, scalable system designs
- Comfort operating in fast-growth environments with ambiguity and evolving requirements
- Excellent organizational and communication skills
- Self-awareness, integrity, authenticity, and a growth mindset
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Cellares Company Size
Between 50 - 200 employees
Cellares Founded Year
2019
Cellares Total Amount Raised
$355,000,000
Cellares Funding Rounds
View funding detailsSeries C
$255,000,000 USD
Series B
$82,000,000 USD
Series A
$18,000,000 USD