QC Lab Startup Leader, Operational Readiness

CamWebDir; Wilmington (DE); On-site; USD 129,000 - 203,000; Full time

Job summary

Merck in Wilmington is seeking a Quality Control Associate Director, Operational Readiness to lead end-to-end laboratory startup and ongoing readiness across QC operations for a large molecule program. You will drive cross-functional planning with Quality, Manufacturing, IT, and R&D to ensure inspection readiness and regulatory compliance.

The role requires a minimum of 10 years in QC/analytical lab ops, strong leadership, and experience with startup activities, SOPs, data integrity, and

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Engineering, or a related scientific discipline is required; advanced degree preferred.
• Minimum of 10 years of relevant experience in Quality Control, analytical laboratory operations, pharmaceutical/biotech manufacturing support, or a related regulated scientific discipline, with demonstrated progression in responsibility.
• Demonstrated leadership experience in laboratory operations, operational readiness, large-scale start-up, capital project support, or complex cross-functional program execution is required.
• Proven experience leading cross-functional teams, governance forums, or workstreams across Quality, Manufacturing, Supply Chain, Engineering, IT/Digital, and analytical development stakeholders.
• Strong experience with laboratory start-up activities, including equipment and system readiness, SOP and training readiness, sample management, inventory/material readiness, stability operations, and inspection readiness.
• Strong quality background with direct experience supporting internal audits, regulatory inspections, readiness assessments, or health authority inspection preparation.
• Experience in cGMP environments, QC laboratory operations, data integrity expectations, and quality management systems is required.
• Strong working knowledge of laboratory and quality systems such as LIMS, inventory systems, Veeva, Kneat, MODA, Empower, SAP, or other digital laboratory tools is preferred.
• Experience providing leadership oversight for deviation/OOS investigations, change controls, CAPAs, quality risk assessments, and continuous improvement initiatives.
• Demonstrated Lean, Six Sigma, operational excellence, or continuous improvement experience preferred.
• Formal project management experience or PMP certification preferred.

Responsibilities

• Lead the end-to-end QC laboratory operations readiness strategy, integrated planning, and execution for Wilmington start-up and transition to routine operations.
• Provide cross-functional leadership across laboratory start-up, sample management, materials readiness, stability operations, SOPs, training, and inspection readiness.
• Translate startup objectives into a single executable readiness plan aligned to the site Integrated Master Schedule.
• Establish governance, escalation, and accountability across Quality, Manufacturing, Supply Chain, Facilities, IT, and R&D teams.
• Ensure compliance with cGMP, data integrity, and regulatory requirements through audits, CAPAs, and change controls.
• Drive continuous improvement and readiness improvements through standard work, digital enablement, and lean initiatives.
• Oversee deviation/OOS investigations, readiness assessments, and inspection preparedness to support facility approvals.

Skills

Cross-Functional Leadership

Quality Assurance

Analytical Method Development

Data Integrity

GMP

Project Management

Education

Bachelor’s degree in Chemistry, Biochemistry, Engineering

Tools

LIMS

SAP

Veeva

Kneat

MODA

Empower

Job description

Merck in Wilmington is seeking a Quality Control Associate Director, Operational Readiness to lead end-to-end laboratory startup and ongoing readiness across QC operations for a large molecule program. You will drive cross-functional planning with Quality, Manufacturing, IT, and R&D to ensure inspection readiness and regulatory compliance.

The role requires a minimum of 10 years in QC/analytical lab ops, strong leadership, and experience with startup activities, SOPs, data integrity, and