Overview
Provides strategic and operational Quality Control (QC) leadership for laboratory operations spanning Phase 2 clinical development through Commercial manufacturing. Accountable for project management of laboratory operations, including schedule planning, schedule adherence, and execution against manufacturing and supply chain timelines. Leads the development and use of dashboards for sample management, throughput, and On-Time-In-Full (OTIF) performance metrics.
Responsible for planning, coordination, and execution of QC activities across raw material testing, commercial product testing, stability programs, analytical and cleaning method development, and method transfers. Accountable for achieving QC targets and KPIs, managing budgets, and developing a high-performing, cross-trained QC organization with robust succession and backup coverage for critical roles.
Detailed Description
Laboratory Operations & Project Management
- Provides end-to-end laboratory operations management from Phase 2 clinical development through Commercial production
- Leads project management of laboratory activities, ensuring alignment with manufacturing schedules, regulatory commitments, and product launch timelines
- Develops and manages laboratory master schedules, including sample planning, resource loading, and schedule adherence
- Ensures laboratory deliverables are completed On Time In Full (OTIF) in support of manufacturing, release, stability, and regulatory submissions
- Creates and maintains operational dashboards to track:
- Sample throughput
- Testing cycle times
- OTIF performance
- Capacity utilization and backlog
- Proactively identifies risks to timelines and implements mitigation plans
Testing & Technical Oversight
- Oversees physical, chemical, and microbiological testing of:
- Raw materials
- In-process and finished products
- Stability samples
- Special and investigational samples
- Provides oversight for:
- Raw material qualification and testing
- Commercial product release testing
- Stability testing programs
- Ensures accurate documentation, review, and submission of raw data and results in LIMS
- Oversees preparation of reagents and microbiological media, including growth promotion testing
- Provides technical oversight for advanced analytical techniques, including:
- HPLC, UPLC, GC, ICP-MS
- Ensures data integrity and compliance through robust data review and lot disposition support
Method Development, Validation & Transfer
- Leads and oversees:
- Analytical method development
- Analytical method validation and verification
- Analytical method transfer (internal and external)
- Cleaning method development
- Cleaning method validation and transfer
- Provides technical and strategic oversight for new product introductions and lifecycle management activities
- Ensures method readiness to support clinical progression, commercialization, and post-approval changes
Quality Systems, Compliance & Investigations
- Leads laboratory OOS, OOT, and atypical investigations, ensuring timely, compliant, and scientifically sound conclusions
- Provides compliance leadership and subject matter expertise for the QC department
- Supports and sustains a continuous audit readiness program to ensure inspection-ready state at all times
- Continuously monitors and improves QC systems and procedures to enhance:
- Regulatory compliance
- Data integrity
- Operational efficiency
- Industry best practices
- Supports QC Systems Administration activities, including Empower, LIMS, and TrackWise
- Support Vendor Audits as the SME for third party laboratories
Leadership, Talent Development & Continuous Improvement
- Effectively leads and coaches QC staff and lab management to achieve departmental goals
- Establishes daily priorities and allocates resources to meet operational and project needs
- Develops and executes analyst training and cross-training programs
- Conducts performance and development reviews and determines merit increases
- Recruits, interviews, and hires qualified technical and support staff
- Drives continuous improvement initiatives to enhance laboratory efficiency, throughput, and right-first-time performance
- Represents QC on site-level and cross-functional project teams
Budget & Capital Management
- Prepares, manages, and administers the QC laboratory operating and capital budgets
- Tracks budget performance against plan and implements corrective actions as needed
- Oversees implementation of key laboratory projects, including:
- LIMS deployments and enhancements
- TrackWise implementations
- Equipment qualification (IOPQ/PQ)
- Capacity expansion initiatives
Responsibilities
- Provide strategic leadership and operational execution for QC laboratory activities
- Ensure laboratory schedules, deliverables, and metrics align with business and regulatory needs
- Maintain a compliant, efficient, and inspection-ready QC organization
- Develop talent, build bench strength, and promote a culture of accountability and continuous improvement
Qualifications
- Bachelor’s degree in Chemistry, Biology, Microbiology, or related scientific discipline (advanced degree preferred)
- Minimum 10 years of technical experience and 7 years of leadership experience in a GMP-regulated environment
- Experience in a CDMO environment preferred.
- Demonstrated project management experience within laboratory operations
- Strong written, verbal, and interpersonal communication skills
- Proficiency with Microsoft Word, Excel, PowerPoint, and data visualization for dashboards and metrics
- Strong background in analytical chemistry and/or microbiological testing
- Expertise with HPLC, UPLC, and GC systems
- Proven leadership capabilities, including:
- Building effective teams
- Strategic mindset and business insight
- Problem-solving and decision-making
- Resource and stakeholder management
- Change leadership and execution
