QC Lab Ops & Operational Readiness Senior Specialist

Job Description

Reporting to the QC Laboratory Operations Manager, the Laboratory Operations Senior Specialist – Operational Readiness is accountable for end‑to‑end QC laboratory operational readiness planning and execution in support of the new Wilmington Biotech Campus QC Laboratory.
The role integrates laboratory operations work streams, including equipment, system, and laboratory start‑up readiness activities, into a single executable readiness plan aligned to the site Integrated Master Schedule.

• Build, maintain, and govern the QC laboratory operations readiness schedule across work streams aligned to the site Integrated Master Schedule and critical path.
• Drive schedule convergence and acceleration by identifying dependencies, sequencing conflicts, resourcing gaps, and pull‑forward actions; support weekly look‑ahead planning and escalation for overdue/at‑risk deliverables.
• Establish laboratory operations readiness stage‑gates and define entry/exit criteria with stakeholders to confirm readiness at critical milestones.
• Partner with cross‑functional stakeholders (Quality, Manufacturing, Supply Chain, Facilities/Engineering, Research division, and IT) to align laboratory operations readiness with site start‑up timelines.
• Coordinate drafting, review, and approval of SOPs, Work Instructions, and Job Aids for laboratory operations activities and maintain a document tracker integrated into the master readiness schedule.
• Develop the end‑to‑end sample management process (receipt, login, storage, tracking, distribution, retention/disposal) and implement sample workflows within LIMS to ensure chain of custody, traceability, and data integrity compliance.
• Develop inventory control processes for consumables, chemicals, reagents, reference standards, and supplies; coordinate supplier readiness, material master data, reorder points, and procurement workflows aligned to start‑up sequencing.
• Support stability operations including design oversight, start‑up of the stability facility, and process development for sample pull scheduling, storage condition management, and distribution.
• Ensure all laboratory operations activities comply with cGMP, corporate quality policies, and regulatory requirements (FDA, EMA, ICH); maintain inspection readiness at all times and embed data integrity principles (ALCOA+).
• Lead or support deviation investigations, OOS/OOT assessments, root cause analyses, and CAPAs related to laboratory operations; manage change controls for processes, systems, and materials.
• After go‑live, support long‑term daily requirements for sample management, solution/reagent preparation, inventory management, planning/scheduling, and stability activities; monitor operational KPIs and drive corrective actions.
• Drive continuous improvement through standard work, lean practices, and automation opportunities; benchmark against network best practices.

• Education:
  
  Bachelor’s degree in Chemistry, Biochemistry, Engineering, or a related scientific discipline (advanced degree preferred).
• Minimum 6 years of industry experience working directly in QC testing in a biotech, pharmaceutical, or related discipline.
• Proven experience with laboratory start‑up projects and formal project management experience (PMP preferred).
• Strong quality background with direct experience supporting health authority inspections in a cGMP environment.
• Experience with QC laboratory operations, quality management systems, and quality information systems (e.g., Veeva, Kneat, Biovia).
• Knowledge of deviation/OOS investigations, change control, and CAPA processes; familiarity with data integrity principles.
• Demonstrated Lean/Six Sigma or continuous improvement experience.

• Strong organizational skills, ability to manage multiple priorities in a dynamic start‑up environment.
• Cross‑functional collaboration and stakeholder integration.
• Attention to detail with commitment to data integrity, compliance, and right‑first‑time execution.
• Problem‑solving, risk assessment, and clear escalation framing.
• Proactive quality mindset and ability to drive change and continuous improvement.

• Location:
  
  Wilmington,…